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Seitentitel

GMP-Verlag Peither AG | Good Manufacturing Practice | GMP Pharma

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Seitenbeschreibung

We are supporting you on your journey to GMP Compliance. Are you looking for the GMP Compliance Adviser, the most comprehensive GMP online knowledge portal worldwide, combining theory and practice?

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Quality Management, Quality Risk Management & Quality Control Premises, Facilities & Media Qualification, Process Validation & Cleaning Validation

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url https://www.gmp-publishing.com/
type website
site_name GMP-Verlag Peither AG
title GMP-Verlag Peither AG | Good Manufacturing Practice | GMP Pharma
description We are supporting you on your journey to GMP Compliance. Are you looking for the GMP Compliance Adviser, the most comprehensive GMP online knowledge portal worldwide, combining theory and practice?
image https://www.gmp-publishing.com/media/c7/d8/bc/1753359785/gmp-logo.png?ts=1753359804

Überschriften

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  • [H1] GMP Knowledgefor Your Safety.
  • [H2] The GMP Knowledge Portals
  • [H2] Why GMP-Verlag?
  • [H2] The Range of GMP Products
  • [H2] Current GMP Topics
  • [H2]
  • [H2] Don't miss out on important information anymore.
  • [H3] Get to know the GMP Compliance Adviser.
  • [H3] GMP Compliance Adviser
  • [H3] GMP:KH Pharma Logistics (GDP)
  • [H3] 1. Up-to-date
  • [H3] 2. Practice-oriented
  • [H3] 3. Reliable
  • [H3] 4. Comprehensible
  • [H3] 5. Supportive
  • [H3] EMA: Pilot Programme for Breakthrough Devices
  • [H3] EDQM: New Ph. Eur. Chapter on Data Quality with a Focus on Digital Data
  • [H3] PIC/S: Jordan FDA Joins PIC/S
  • [H3] Swissmedic: Scientific GMDP Meetings
  • [H3] Purified Water – The new Chinese Pharmacopoeias and What Happens Next?
  • [H3] What are the requirements for gas distribution systems?
  • [H3] What are the quality requirements for pharmaceutical gases?
  • [H3] EMA: Update on the Guideline “Stability Testing for Variations”
  • [H3] EU: Proposal for Simplification of Medical Device Rules
  • [H3] EU: Proposal for a European Biotech Act
  • [H3] EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals
  • [H3] EMA: Q&A on QP Certification Without Physical EU Import
  • [H3] EU: Agreement on the Pharmaceutical Package
  • [H3] EMA: Updated Q&As for Biological Medicinal Products
  • [H3] ICH: New Recommendations for the Manufacture of ATMPs
  • [H3] GMP Publishing Embarks on a new Digital Chapter
  • [H3] What should be considered in risk assessment?
  • [H3] Basics on the Integrity of Container Closure Systems
  • [H3] PAT CONNECT 2026: Register now!
  • [H3] EU: First Four EUDAMED Modules Mandatory from 28 May 2026
  • [H3] Swissmedic: Digital Package Leaflet Instead of Paper
  • [H3] EMA: 6 New Nitrosamines for Appendix 1
  • [H3] EMA: Updated Q&A on Combination Products
  • [H3] ICH: Assembly Meeting 2025
  • [H3] How is a QRM process initiated?
  • [H3] FDA: Updated Pre-RFD Guidance for Combination Products
  • [H3] EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs
  • [H3] Data Integrity and Data Governance
  • [H3] EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines
  • [H3] EMA Clarifies “Novel or Complex Manufacturing Process” Definition
  • [H3] Operation of Computerised Systems – An Overview
  • [H3] What are the individual steps of an efficient QRM process?
  • [H3] EU: GMP Implementing Regulations for Veterinary Medicinal Products
  • [H3] EDQM: Stepwise Process to Getting a CEP
  • [H3] IPEC: Updated Questionnaire for Excipient Nitrosamine Risk Evaluation
  • [H3] FDA: Shift Back to Generalist Inspectorate
  • [H3] Data Integrity in the QC Laboratory
  • [H3] How should change management be documented?
  • [H3] EDQM: Automated CEP Submissions From 1 November 2025
  • [H3] EC: Updated List of Harmonised Standards for Medical Devices
  • [H3] Quality Assurance – Current Status and Outlook
  • [H3] In which areas should change management be applied and who is responsible for implementation?
  • [H3] EMA: Update of Q&As for Nitrosamine Impurities
  • [H3] DIN EN ISO 14644-5:2025: Updated Standard for Cleanroom Operations
  • [H3] EMA: Reliance on FDA Inspections Outside the United States
  • [H3] EMA: In-Use Stability Testing of Veterinary Medicinal Products
  • [H3] PIC/S New Pre-Applicants: Nigeria, Tanzania, Rwanda and Senegal
  • [H3] Advancing Data Integrity: New Challenges and Practical Solutions
  • [H3] What methods are used for testing leakage?
  • [H3] FDA: Guidance on Computer Software Assurance (CSA)
  • [H3] FDA Guidance: Alternative Tools for Site Assessments
  • [H3] EC: New Entries in the MDCG Borderline Manual
  • [H3] What is essential for the structure of container closure systems used for product packaging?
  • [H3] PDA: AI Glossary Available Online
  • [H3] EC: Targeted Revision of MDR and IVDR
  • [H3] MedTech Europe: Urges Alignment of EU Digital Laws With Medical Device Rules
  • [H3] EMA: 13 New Nitrosamines for Appendix 1
  • [H3] EC: Revised Chapter 1 of the EU GMP Guide Published
  • [H3] How can subjectivity in the QRM process be minimized?
  • [H3] EMA: Update of the GACP Guideline Published
  • [H3] FDA: 2024 Report on the State of Pharmaceutical Quality
  • [H3] Meet GMP-Verlag at POWTECH TECHNOPHARM 2025
  • [H3] Facts or Intuition – How Reliable is Your Risk Analysis?
  • [H3] What is required for risk-based decision-making?
  • [H3] Swissmedic: Adoption of EU Regulation 2025/1234 on use of Electronical Instructions for Medical Devices
  • [H3] WHO: New WHO-Listed Authorities Designated
  • [H3] ICH: ICH Q3 Draft on Extractables and Leachables Released
  • [H3] What determines the level of effort, rigour and formality with which QRM is applied?
  • [H3] EMA: Report on Nitrosamine Impurities
  • [H3] Pharmaceutical Gases – Operation, Maintenance and Monitoring of Gas Distribution Systems
  • [H3] Change Management from an Authorities' Perspective
  • [H3] The Draft ICH Q1 Guideline: A Fresh Take on Stability
  • [H3] VDI: Update of Cleanroom Standards 2083 4.1 and 2083 4.2
  • [H3] Ph. Eur.: Revised Monographs on Pharmaceutical Water
  • [H3] What information should be covered by the validation report?
  • [H3] ISPE: New GAMP® Guide on Artificial Intelligence
  • [H3] Ph. Eur.: Revised Chapter on Glass Containers
  • [H3] USP: Revision of 1231 Water for Pharmaceutical Purposes
  • [H3] EDQM: Egypt is a new Associated Member to the OMCL Network
  • [H3] EU GMP Guide: Chapter 4, Annex 11 and New Annex 22
  • [H3] What information should be included in the validation plan?
  • [H3] EU: Dual Application of MDR/IVDR and AI Act for AI-Based Medical Devices
  • [H3] Swissmedic: New Technical Interpretation on the Return of Medicinal Products
  • [H3] Operation of Computerised Systems – Implementation and Commissioning
  • [H3] GMP or GDP – Would You Have Known?
  • [H3] Why do analytical test methods need to be validated?
  • [H3] APIC: Updated Nitrosamine Guidance
  • [H3] What is a validation test?
  • [H3] FDA: Launch of “Elsa” AI Tool
  • [H3] EU: Council Agrees on Position for the 'Pharma Package'
  • [H3] PDA Good Aseptic Manufacturing Conference 2025: The Annex 1 Reality Check
  • [H3] Water Qualities – Water for Injection (WFI)
  • [H3] Swissmedic: Amendment to GMP Compliance by Foreign Manufacturers
  • [H3] EDQM: Revised Guideline “How to Read a CEP”
  • [H3] ICH: Assembly Meeting 2025
  • [H3] EMA: Updated Q&A on Nitrosamines in Human Medicinal Products
  • [H3] What do the abbreviations VP and VR mean?
  • [H3] AI in the GMP Environment: What do the Regulators Expect?
  • [H3] EU: 6 New Nitrosamines for Appendix 1
  • [H3] EMA: FAQs on the European Shortages Monitoring Platform (ESMP)
  • [H3] What are the phases of the quality risk management process?
  • [H3] Swissmedic: Requirement for Risk Assessment Relating to Nitrosamines
  • [H3] EMA: Concept Paper on the Revision of GMP Guide Part IV on ATMPs
  • [H3] FDA: Unannounced Inspections at Foreign Manufacturing Facilities
  • [H3] EMA: New Q&A on Third Party Audits in the QP Declaration
  • [H3] Water Qualities – Purified Water
  • [H3] Artificial Intelligence in Pharmaceutical GMP – a World of Possibilities
  • [H3] What advantages does quality risk management have for the company?
  • [H3] WHO: New Technical Report (TRS 1060) Published
  • [H3] ICH: Revised ICH Q1 Draft for Consultation
  • [H3] How can QRM be used?
  • [H3] EMA: 2 New Q&As on Third Party Audits of API Suppliers
  • [H3] Good Storage and Distribution Practice: What is the WHO GSDP Guideline about?
  • [H3] Swissmedic: Update of the Technical Interpretation for PQR
  • [H3] China: Draft Revision of GMP Annex for Sterile Drugs
  • [H3] EMA: Draft Reflection Paper on Linking ePI from Medicine Packages
  • [H3] How do we deal with risks?
  • [H3] EMA: GMDP IWG 3-Year Work Plan (2025–2027)
  • [H3] EMA: Annual Report of the GMDP IWG 2024
  • [H3] Water Qualities – Drinking Water as Source Water
  • [H3] What options are there for evaluating the Quality System?
  • [H3] ICMRA: Extension of PQKM Collaborative Pilots
  • [H3] What does quality oversight mean?
  • [H3] EC: Proposal for the Critical Medicines Act
  • [H3] Quality Risk Management: What’s new in ICH Q9(R1)?
  • [H3] IPEC: Updated Position Paper on Third Party Audits
  • [H3] EMA: Pilots for Post-Authorisation Changes
  • [H3] How are responsibilities split between Quality Control and Quality Assurance?
  • [H3] EMA: Updated Q&As for Biological Medicinal Products
  • [H3] Who is responsible for establishing the Pharmaceutical Quality System and making it work?
  • [H3] EMA: Nitrosamine Impurities – New: Champix Section
  • [H3] How to Implement Quality Oversight at Shop Floor Level
  • [H3] What means Limit of Quantitation (LOQ)?
  • [H3] EU: 11 New Nitrosamines for Appendix 1
  • [H3] India: Deadline Extension for Implementation of Schedule M
  • [H3] Swissmedic: Portal Update
  • [H3] What is a Certificate of Analysis (COA)?
  • [H3] MDCG: Notified Bodies and Use of Previous Assessments
  • [H3] Regulatory Requirements for the Validation of Analytical Methods – Part 2
  • [H3] What is a Biosafety Level (BSL)?
  • [H3] EMA: 3 new Q&As on Diethylene Glycol (DEG) and Ethylene Glycol (EG)
  • [H3] EMA: Appendix 1 on Nitrosamines Amended
  • [H3] BfArM: AMIce Public Part Becomes Completely Free of Charge
  • [H3] Swissmedic: Refined Interpretation of the MRA with Canada
  • [H3] EC: New Biotech and Biomanufacturing Hub
  • [H3] What does Annual (Product) Review mean?
  • [H3] EMA: Draft for Qualification of Non-Mutagenic Impurities
  • [H3] Regulatory Requirements for the Validation of Analytical Methods – Part 1
  • [H3] What are endotoxins and what are their effects?
  • [H3] PIC/S: New Partnership with African Union Development Agency
  • [H3] What requirements for "Good Distribution Practice" can be found in national and international regulations?
  • [H3] WHO: Draft Guidance on Continuous Manufacturing
  • [H3] FDA: Guidance to Ensure Batch Conformity and Drug Product Integrity
  • [H3] EMA: Update of Appendix 1 for Nitrosamines
  • [H3] How is pure steam produced and used?
  • [H3] MHRA: Further Guidance on Windsor Framework
  • [H3] Supply Shortages – is a Solution in Sight?
  • [H3] What are the different types of pharmaceutical water?
  • [H3] Swissmedic: Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs)
  • [H3] FDA: Updated Nitrosamine Limits
  • [H3] What special features need to be considered when determining the total microbial count in pharmaceutical water?
  • [H3] Where can I find specific information on the subject of "transport and temperature"?
  • [H3] EMA: Implementation of Electronic Product Information
  • [H3] EMA: New Q&As for Wholesale Distributors/Brokers on Suspicious Offers
  • [H3] PIC/S: Guidance on Remote Assessments
  • [H3] What information must be included in the microbiological monitoring plan?
  • [H3] ICH: Updated Q9(R1) Annex 1 – Q8/Q9/Q10 Questions & Answers
  • [H3] WHO: 2 More African Countries Reached Maturity Level 3
  • [H3] EMA: Work Plan for the Quality Innovation Group
  • [H3] How is a physicochemical monitoring program structured?
  • [H3] ANVISA: Relying on International Evaluation Reports
  • [H3] EDQM: CEPs for Sterile Substances
  • [H3] Which filters are used in safety cabinets, and which filter tests are to be carried out?
  • [H3] EDQM: General Chapter „Elemental Impurities (G-07)“ Harmonised
  • [H3] ICH: Q13 Video Training Material Modules 1–12
  • [H3] Physicochemical Monitoring of Pharmaceutical Water
  • [H3] What special factors need to be considered for sterile filtration?
  • [H3] EC: Q&As on Gradual Roll Out of EUDAMED
  • [H3] EMA: New Q&A on Supply Chain Traceability
  • [H3] Isolators – Design and Application
  • [H3] What needs to be considered when validating a sterility test method?
  • [H3] ICH: Assembly Meeting 2024 Recap
  • [H3] EDQM: Ph. Eur. in Online-Only Format from June 2025
  • [H3] What are isolators and what are they used for in the pharmaceutical industry?
  • [H3] PMDA Opens Office in the USA
  • [H3] EDQM: First Turkish OMCL now a Member of the OMCL Network
  • [H3] Filters and Installations in Safety Cabinets
  • [H3] EC: Q&A Information on Interruption or Discontinuation of Supply of Medical Devices
  • [H3] ICH: Q9(R1) Updated Training Materials
  • [H3] What is the EDQM and what are its tasks?
  • [H3] What is the EMA and what tasks does it fulfil?
  • [H3] EU: Parliament Votes to Revise MDR and IVDR
  • [H3] Which parameters are relevant in the monitoring of pharmaceutical water?
  • [H3] EC: Guidance on Qualification of IVDs
  • [H3] Materials and Adjuvants for Pharmaceutical Equipment Construction – An Overview
  • [H3] What types of cabinets are available?
  • [H3] ICH: Report of 2024 Implementation Survey
  • [H3] What needs to be taken into account when using and maintaining safety cabinets?
  • [H3] EMA: Draft Guideline on Elemental Impurities in Veterinary Medicines
  • [H3] Where can you find regulatory requirements for isolator technology?
  • [H3] Anvisa: Dashboard with List of APIs Awaiting Registration
  • [H3] Swissmedic: SwissGMDP Database Launched
  • [H3] Sterilisation Processes – Requirements and Definitions
  • [H3] Insights from the PDA/FDA Joint Regulatory Conference 2024
  • [H3] What needs to be considered when validating a sterility test method? (2024)
  • [H3] EMA: New Q&As for Co-processed Excipients Used in Solid Oral Dosage Forms
  • [H3] MHRA: Guidance for Manufacturers Following Revised Brexit Deal
  • [H3] What special factors need to be considered for sterile filtration? (2024)
  • [H3] EMA: Revision 6 of the Appendix 1 on AIs for N-Nitrosamines
  • [H3] FDA: Control of Nitrosamine Impurities
  • [H3] PDA: New Publications and Formation of the D/A/CH Chapter
  • [H3] EMA: Guiding Principles on LLMs, a Category of Generative AI
  • [H3] What requirements are placed on cleanroom personnel?
  • [H3] Swissmedic: Update of Responsible Person Requirements
  • [H3] What is the Sterility Assurance Level (SAL)?
  • [H3] EMA: Revision of Guideline on Environmental Risk Assessment (ERA) enters into force
  • [H3] DRA Pakistan: Rapid Alert on Falsified Propylene Glycol
  • [H3] How can a sterilisation process be checked?
  • [H3] CDSCO: Indian Agency Drafts Revised GDP Guidelines
  • [H3] Which sterilisation methods are used in the manufacture of sterile products?
  • [H3] Swissmedic: Updated Information on Non-Standardized Medicinal Products
  • [H3] Concepts for the Separation of Clean Rooms
  • [H3] EMA: Updated Q&As on the Impact of the EU-US MRA
  • [H3] TGA: Australia Consults on Partially Harmonising with EU MDR/IVDR
  • [H3] Sterile Filtration (PUPSIT)
  • [H3] What are the legal requirements for plastics?
  • [H3] Swissmedic: First Module of Medical Devices Database live
  • [H3] What should be considered when selecting a suitable sealing material?
  • [H3] TGA: New GMP Inspection Arrangements
  • [H3] Which lubricants can be used in a GMP environment?
  • [H3] EMA: Updated Q&A on Nitrosamines 2024
  • [H3] FDA: Draft Guidance for Manufacturing Changes of Biosimilars
  • [H3] EMA: Revised Guideline on the Chemistry of Active Substances
  • [H3] In-house Logistics: Material Management in Pharmaceutical Companies
  • [H3] Is it Permissible to Use Analysis Results From External Laboratories?
  • [H3] Which different types of stainless steel are available?
  • [H3] EU: New Regulation on Substances of Human Origin (SoHO)
  • [H3] What general hygiene measures need to be observed in storage areas?
  • [H3] EMA: Updated Appendix 1 of the Nitrosamine Q&As
  • [H3] EU Updates MDR and IVDR
  • [H3] Which phases characterise the life cycle of a computerised system?
  • [H3] EC: Updated MDR/IVDR Guidance on Standardisation for Medical Devices
  • [H3] Japan: Updated Translation of the MHLW Standard for Manufacturing and Quality Control
  • [H3] Why does it take a year to qualify the performance of a water supply system?
  • [H3] EDQM: New General Chapter on Extractable Elements in Plastic Materials Adopted
  • [H3] EU: Cooperation of EMA and EC under the Health Technology Assessment Regulation
  • [H3] What does reprocessing mean in the production of APIs?
  • [H3] EC: Updated Guide for Designation and Notification of Notified Bodies
  • [H3] EMA: Templates for Medicine Shortage Prevention and Mitigation
  • [H3] How are Quality Culture and a Symphony Orchestra Similar?
  • [H3] What does the catchphrase "Supply Chain Integrity" mean?
  • [H3] Clean up Period and Recovery Time
  • [H3] ICH: Assembly Meeting in Japan 2024 Recap
  • [H3] EFPIA: Sustainability Statement
  • [H3] Agency Expectations on PDE Determination and PDE Reports
  • [H3] What is DIN Spec. 91323?
  • [H3] Why do Manufacturing and Packaging Processes Have to be Validated?
  • [H3] What is the advantage of Building Information Modeling (BIM) for planning new premises?
  • [H3] EU: Revised Device Surveillance Guidance
  • [H3] ICH Q2(R2)/Q14 Training Presentation
  • [H3] What is adjustment?
  • [H3] EC: Q&As on Safety Features – New Version
  • [H3] EMA: Revised Q&As on Implementation of MDR and IVDR
  • [H3] EDQM: Draft Guideline on ‘Content of the Dossier for Sterile Substances’
  • [H3] Contamination Control Strategy – What is the Inspector’s Point of View?
  • [H3] What must be observed when planning and designing distribution systems for pure steam?
  • [H3] EMA: Nitrosamines Appendix 1 Updated
  • [H3] EMA: Remote Activities of the Responsible Person (GDP)
  • [H3] What quality requirements must pure steam meet?
  • [H3] FDA: Final Guidance on “Remanufacturing“ of Medical Devices
  • [H3] What are the basic physical principles of steam generation?
  • [H3] EMA: Guidance on Sampling Excipients at High Risk of Glycol Contamination
  • [H3] FDA: Final Rule Declares Laboratory Developed Tests to be Medical Devices
  • [H3] WHO: Draft for the Prevention and Control of Nitrosamine Contamination
  • [H3] What do the authorities expect during the first inspections after the revised Annex 1 came into force?
  • [H3] EMA: GMDP IWG Work Plan 2024 - 2026
  • [H3] What is the focus for personnel in the revised Annex 1?
  • [H3] EMA: Draft Revision of GACP Guideline Published
  • [H3] What was the reason for the revision of Annex 1?
  • [H3] Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 2
  • [H3] EDQM: European and Japanese Pharmacopeias Launch Harmonisation Project
  • [H3] EU: Parliament Adopts Position on EU Pharmaceutical Reform
  • [H3] Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1
  • [H3] What are the major trends that have recently changed the concept of validation?
  • [H3] PMDA: English Version of Biosimilar Q&As
  • [H3] What must be observed when working with gloves in isolators?
  • [H3] Nitrosamines: EMA updates Appendix 3 of the Q&A
  • [H3] 30 Years of GMP - A Personal View on Good Manufacturing Practices
  • [H3] German Cannabis Law Comes into Force on 1 April
  • [H3] How do you develop a process management and control strategy?
  • [H3] For what purposes are isolators used?
  • [H3] EC: Harmonised Standards for Medical Device Sterilisation
  • [H3] Sources of Contamination: Rooms and Facilities
  • [H3] How can the specific requirements for sterile products be taken into account in the quality management system?
  • [H3] ECJ: European Standards Should be Freely Accessible
  • [H3] Cannabis GMP Wiki planned
  • [H3] Which quality and process parameters must typically be taken into account during process validation for terminally sterilized products?
  • [H3] EMA: 14 New/Updated Acceptable Intakes for N-nitrosamines
  • [H3] Tests in the New Ph. Eur. Monograph on Cannabis Flower
  • [H3] German Bundestag Passes Cannabis Law
  • [H3] What do typical manufacturing processes look like?
  • [H3] ICH: ICH Q12 Module 8 Training Material is Available
  • [H3] ICH: Revision 9 of ICH Q3C Guideline Finalised
  • [H3] What are facility control systems used for?
  • [H3] EDQM: TOP 10 Deficiencies in New CEP Applications
  • [H3] Who is responsible for the existence and effectiveness of deviation management?
  • [H3] MHRA: Designation of Two New UK Approved Bodies
  • [H3] WHO: New Edition of the GMP Compendium for Medical Products
  • [H3] FDA: Medical Devices – Quality System Regulation Amendments
  • [H3] What is cloud computing?
  • [H3] Swissmedic: Risk Assessment for Nitrosamine Drug Substance-Related Impurities (NDSRI)
  • [H3] What has to be considered when releasing batches with deviations?
  • [H3] EDQM: Confidentiality and Declassification of CEP Documents
  • [H3] India: Health Ministry Revised Schedule M for GMP
  • [H3] Swissmedic: Invalid Certification of the Notified Body ECM
  • [H3] What is the purpose of process visualisation?
  • [H3] EMA: 3 new Q&As on EU GMP Annex 1
  • [H3] EMA: 7 Q&As on In-use Shelf Life of Sterile Products After Opening/Reconstitution
  • [H3] Can GMP Data be in the Cloud?
  • [H3] What is a deviation?
  • [H3] EMA: Q&A on Brexit Rules for Centrally Authorized Medicinal Products in Northern Ireland
  • [H3] Which GxP critical aspects are affected when storing data in the cloud?
  • [H3] EDQM: Ph. Eur. Reference Standards for Cannabis Flowers now Available
  • [H3] What is the difference between a corrective action and a preventive action?
  • [H3] What requirements must cleaning processes meet in terms of cleaning validation?
  • [H3] What is the difference between a correction and a corrective action?
  • [H3] MHRA: Alignment With EU on Extention of GMP and GDP Certificates
  • [H3] European Commission: EU Reference Laboratories Designated for IVDs
  • [H3] EMA: Validity of GMP and GDP Certificates in 2024
  • [H3] EDQM: Ph. Eur. Pre-publishes Revised Propylene Glycol Monograph
  • [H3] What factors influence cleaning?
  • [H3] EMA: Q&A on Use of X-Ray Sterilisation
  • [H3] Latest News from PIC/S
  • [H3] What is meant by the term 'CAPA' or 'CAPA management'?
  • [H3] How can the Life Cycle Approach be Applied to Cleaning Validation?
  • [H3] How should the qualification be documented?
  • [H3] Swissmedic: Technical Interpretation on Annex 1 Published
  • [H3] GMP Question of the Week: Top 15 in 2023
  • [H3] How should one handle qualification data?
  • [H3] MedTech Europe: Vision for MDR/IVDR Reform
  • [H3] EMA: Update of Q&A on Nitrosamine Impurities
  • [H3] ICH: Q5A(R2) Guideline on Viral Safety of Biotechnology Products adopted
  • [H3] WHO: Recognition for Swissmedic and two other authorities
  • [H3] Who is responsible for qualification?
  • [H3] ICH: Parallel Guidances Q2(R2)/Q14 on Analytical Procedures adopted
  • [H3] Nothing lasts Forever: Stability Tests are Indispensable
  • [H3] What is the importance of plant design for qualification?
  • [H3] MHRA: Regulatory ‘Sandbox’ for AI Developers
  • [H3] Operation Pangea XVI: Global Illicit Medicines Targeted by INTERPOL Operation
  • [H3] When is a determination of the conductivity useful in cleaning validation?
  • [H3] European Commission: Steps to Ensure the Availability of Medicines
  • [H3] Submit IVDR Applications for Class D Devices Before the End of 2023
  • [H3] Personnel Hygiene is not a Delicate Matter! – What are Hygiene Programmes for?
  • [H3] What are the advantages and disadvantages of the rinse test for cleaning validation?
  • [H3] ICH: Training materials for the Q9(R1) Guideline
  • [H3] EDQM: Ph. Eur. Pre-Publishes Cannabis Flower Monograph
  • [H3] What are the advantages and disadvantages of the swab test for cleaning validation?
  • [H3] New Cleanroom Standard for Particle Sampling
  • [H3] What cleaning validation sampling procedures are available for which residues?
  • [H3] Swissmedic: FAQ on Pharmacovigilance Updated
  • [H3] EMA: Q&A on Nitrosamines Updated to Rev. 18
  • [H3] What is the official document containing official actions sent by the FDA after a GMP inspection called?
  • [H3] The New ICH Q9 Guideline: The Next Generation of Quality Management
  • [H3] What are responsibilities of the Qualified Person according to EU Annex 16?
  • [H3] EMA: Q&A on Biological Medicinal Products
  • [H3] MedTech: Call for Structural Reform of MDR and IVDR
  • [H3] What are the spatial requirements for the incoming goods and dispatch areas?
  • [H3] WHO: Draft on Good Practices for Pharmaceutical Quality Control Laboratories
  • [H3] Swissmedic: Swiss GMDP database in early 2024
  • [H3] What is an action limit?
  • [H3] Insight at Second Glance - The Human Error and its Root Causes
  • [H3] When is qualification required for rooms and air handling units and when is technical acceptance testing sufficient?
  • [H3] Why is batch-specific identification necessary and how is it done?
  • [H3] Swissmedic: GMP/GDP inspections accreditation for ATMPs
  • [H3] EMA: Q&A on Nitrosamines Updated to Rev. 17
  • [H3] MHRA: Independent Regulation of CE Marking of Medical Devices
  • [H3] FDA: Guidance on Substance-related Nitrosamine Risks
  • [H3] Monitoring of Parameters and Water Quality
  • [H3] Contamination Control – Cleanliness Zone Concepts
  • [H3] What is an alert limit?
  • [H3] PIC/S: Revision of GMP Guide includes new EU Annex 1
  • [H3] What general hygiene measures need to be observed?
  • [H3] What are the risks associated with microbiological monitoring?
  • [H3] MHRA: Guidance on Labelling/Packaging of Medicinal Products
  • [H3] Which two aspects of the storage organisation are GMP/GDP critical?
  • [H3] EC: Updated Q&A on MDR and IVDR
  • [H3] Swissmedic: Mutual Recognition Agreement with US FDA in Force
  • [H3] When travelling...
  • [H3] EMA: Q&A on Remote Batch Certification and QP Residency
  • [H3] Which metrics are subject to monitoring?
  • [H3] EMA: Update Q&A "Centralised Procedures"
  • [H3] Basis of Cleaning Validation: Setting of PDE Limits
  • [H3] EMA: Expiration of Extraordinary COVID-19 Regulatory Flexibility
  • [H3] What should be done with goods that have been rejected, quarantined or returned from the market?
  • [H3] EMA: Q&A on Nitrosamines Updated
  • [H3] Is there a difference between pharma monitoring and I&C system?
  • [H3] FDA/CDER: Revised MAPP on cGMP Surveillance Inspections
  • [H3] Swissmedic: Specialist Group for Nitrosamine Issues
  • [H3] What is the difference between the clean up period according to Annex 1 and the recovery time according to ISO 14644-3?
  • [H3] ICH: Press Release ICH-Assembly Meeting
  • [H3] Which processes are available for reduction of microbial counts in water systems?
  • [H3] TGA: Regulatory requirements for medical devices
  • [H3] GMP/GDP Requirements for Different Storage Areas
  • [H3] Which persons are responsible for storage in the GMP or GDP area?
  • [H3] Regulatory Requirements for Computerised Systems
  • [H3] Air Handling Systems: GMP Compliant Monitoring and Energy-Saving Operation
  • [H3] What are the concepts for protecting clean work areas?
  • [H3] MHRA: New Recognition Routes with Seven Regulatory Partners
  • [H3] What is rouging and how do you deal with the problem?
  • [H3] EMA: EU – US Mutual Recognition Agreement for Veterinary Medicines Inspections
  • [H3] EC: Template for Notified Bodies
  • [H3] Now available: Chapter on Contamination Control Strategy in the GMP Compliance Adviser
  • [H3] New in Annex 1: the Contamination Control Strategy (CCS)
  • [H3] What is a Contamination Control Strategy (CCS) and what does it include?
  • [H3] UK and Switzerland Negotiate New Trade Arrangement
  • [H3] EMA: Annual Report 2022 Published and Workplan for GMDP Updated
  • [H3] EDQM: 21st Edition of the Blood Guide Published
  • [H3] Reference Standards in the Pharmaceutical Laboratory: Procurement and Characterisation
  • [H3] What documents are required for operation of a pharmaceutical water system?
  • [H3] EMA: Guidance for Industry to Prevent Medicine Shortages
  • [H3] What is the difference between cleanroom class and air cleanliness grade?
  • [H3] Biotechnological Medicinal Products: Global Trends and Perspectives
  • [H3] What are the phases that characterise the life cycle of a computerised system?
  • [H3] Swissmedic: Guidance on GMP-Compliance by Foreign Manufacturers and RP Declaration
  • [H3] EU: Proposal on Reform of Pharmaceutical Legislation
  • [H3] What is the purpose of a responsibility matrix?
  • [H3] EMA: Multi-factor Authentication for CTIS Mandatory by June
  • [H3] GMP Compliant Plant Qualification: Software Quality Plan
  • [H3] What is the qualification of a computerised system?
  • [H3] How can conformance with GMP requirements for active substances be proven?
  • [H3] EMA: GCP-Guideline on Computerised Systems and Data Integrity
  • [H3] WHO: Draft on Revised GMP for Excipients in Pharmaceutical Products
  • [H3] greenGMP Supports the Sustainability Goals in the Company
  • [H3] What is the difference between strategic and tactical outsourcing?
  • [H3] EMA: Q&A on Nitrosamines Updated
  • [H3] Swissmedic: Equivalence with New EU MDR/IVDR Timelines
  • [H3] Regulatory and Industrial Standards for the Qualification of Premises and Air Handling Technology
  • [H3] What is the verification of a computerised system?
  • [H3] ICH: Publication of the Introductory Presentation on ICH Q9 (R1)
  • [H3] EU: Q&A on extended MDR transition
  • [H3] What are immunological medicinal products?
  • [H3] EU MDR/IVDR: New Transitional Provisions Enter into Force
  • [H3] FDA: Definition Guidance on Drug Safety in the Supply Chain
  • [H3] Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance
  • [H3] What is the validation of a computerised system?
  • [H3] EU-MDR/IVDR: Reassessment of Notified Bodies Only Every 5 Years
  • [H3] What contracts are usually concluded in outsourcing?
  • [H3] EC: General Political Agreement with UK on Northern Ireland Protocol
  • [H3] Qualification of Water Supply Systems – Introduction
  • [H3] What are the elements of a computerised system?
  • [H3] FDA: ICH Q13 Guideline and Artificial Intelligence in Drug Manufacturing
  • [H3] EU-MDR: European Parliament Votes in Favour of New Transition Periods
  • [H3] EMA: Q&A for Cannabis-Derived Medicinal Products
  • [H3] Which active ingredient manufacturers receive an EU GMP certificate?
  • [H3] Document and Evaluate GMP Audit Information and Findings
  • [H3] Under what conditions may a contract acceptor subcontract activities to third parties?
  • [H3] Which product groups are included under the term immunological medicinal products?
  • [H3] Swissmedic: Validity of GMP Certificates
  • [H3] EMA: ICH Guideline Q9 (R1) on Quality Risk Management – Step 5
  • [H3] Deviations Happen because People Make Mistakes...
  • [H3] In outsourcing, who is responsible for the quality of the medicinal products produced?
  • [H3] PIC/S: Publication of New GDP Guidance Documents
  • [H3] EMA: Use of CTIS mandatory in the EU
  • [H3] What are the objectives of personnel medical examinations?
  • [H3] ICH: Final Publication of Revised ICH Q9 Guideline
  • [H3] USA: Transition to ISO 13485 is getting closer
  • [H3] What is the dual function of protective clothing in pharmaceutical manufacturing?
  • [H3] FDA: Mutual Recognition Agreement with Swissmedic
  • [H3] 7 Questionnaire Blocks for PLC User Requirements
  • [H3] What do inspectors of premises and rooms pay particular attention to?
  • [H3] EMA: ICH Q13 on Continuous Manufacturing Adopted
  • [H3] EMA: Update on GDP-Q&As for Broker Activities
  • [H3] How to Maintain the Qualification Status of Your Equipment
  • [H3] How can the suitability of premises be verified?
  • [H3] To which products does the new Annex 21 to the EU GMP Guide apply?
  • [H3] EMA: Clinical Trials Information System CTIS mandatory in 2023
  • [H3] What is meant by import?
  • [H3] What are the 3 main types of safety features against drug counterfeiting?
  • [H3] EC: Position Paper on 'Hybrid Audits'
  • [H3] What are the advantages of a dynamic e-form?
  • [H3] EC: Changed Labelling Requirements for IMPs
  • [H3] ICH: Final Q13 Guideline on Continuous Manufacturing
  • [H3] At what point may water be used during the performance qualification of a water supply system?
  • [H3] GMP is not ISO 9001 – Where are the Similarities and Differences?
  • [H3] What is a static form?
  • [H3] EMA: Concept Paper on the Revision of EU GMP Annex 11 on Computerised Systems
  • [H3] Access Consortium: Recognition Arrangement in GMP Inspections
  • [H3] Why does the performance qualification of a water supply system take one year?
  • [H3] MHRA: Resumption of International GMP Inspections
  • [H3] Qualification Master Plan: Regulatory Requirements
  • [H3] What is a generic form?
  • [H3] MHRA: Implementation of British Medical Device Regulation Delayed
  • [H3] What are the advantages of integrated qualification?
  • [H3] EMA: Updated Q&A on GMP/GDP Topics
  • [H3] EMA: Updated Q&A on Nitrosamines 2022
  • [H3] What differences are there between electronic document management systems (eDMS) and electronic quality management systems (eQMS)?
  • [H3] TGA: Draft guidance on boundary and combination products
  • [H3] Which phases are distinguished in the performance qualification of a water supply system?
  • [H3] EU: New Data Quality Framework for Medicines Regulation
  • [H3] ICH: The Draft Guideline Q5A(R2) Reaches Step 2
  • [H3] 4 Questions on the Import of Medicinal Products and APIs
  • [H3] What are the main tasks of the Head of Production?
  • [H3] MHRA: DEKRA appointed first new UK Approved Body to certify medical devices since Brexit
  • [H3] MHRA: Extended use of EC Decision Reliance Procedure across Great Britain
  • [H3] What are the advantages and disadvantages of in-line measurement of the conductivity of water for injection (WFI)?
  • [H3] USP: Draft for a Cannabis Monograph
  • [H3] What are endotoxins?
  • [H3] PIC/S: Publication of Revised GMP Annex 1
  • [H3] EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides
  • [H3] EC: MDR, IVDR Manual on Borderline Devices
  • [H3] Can operators of existing systems for the production of highly purified water (HPW) still refer to the Ph. Eur. now that HPW is no longer listed there?
  • [H3] How do APR and PQR differ in terms of the number of batches to be assessed in the review period?
  • [H3] PMDA: English Version on Procedure for Remote Inspections Revised
  • [H3] EMA: Comments on Draft ICH Q2(R2) and ICH Q14 Published
  • [H3] Order now: Comparative document to the final Annex 1: What's new?
  • [H3] What water quality do you use for cold WFI production?
  • [H3] What is the required evaluation period for the Product Quality Review?
  • [H3] EC: Long-awaited EU Annex 1 on Sterile Manufacturing Published
  • [H3] The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems
  • [H3] Why must sterile filters not be used in water systems to retain germs?
  • [H3] What are the responsibilities of the Qualified Person according to EU Annex 16?
  • [H3] FDA: Remote Inspections Will Remain Regular
  • [H3] Who is responsible for the implementation of a Batch Record Review?
  • [H3] CHMP: Extended Deadline for Nitrosamine Step 3 Revision and Q&A update
  • [H3] What are the disadvantages of using activated charcoal filters in water treatment?
  • [H3] Why is it Necessary to “Manage“ Quality?
  • [H3] PANGEA XV: Worldwide Campaign against Falsified and Illegally Imported Medicinal Products
  • [H3] EMA: Concept Paper on Active Substances and Nitrosamine Impurities
  • [H3] What are the main tasks of the Head of Quality Control?
  • [H3] EDQM: Implementation of the 11th Edition of Ph. Eur. – Notification for CEP Holders
  • [H3] Reaching the next GMP Level with Inspection Readiness Projects
  • [H3] What parameters are hidden behind "Feedwater Conductivity Equivalent", and what are they needed for?
  • [H3] EC: Q&A on Nitrosamine Impurities updated
  • [H3] EC: Version 20 of Q&A on Safety Features
  • [H3] What is a Batch Record Review?
  • [H3] EC: Common Specifications for Certain High-Risk IVDs
  • [H3] Definition of Hygiene Zones
  • [H3] Is it reasonable to test purified water for the presence of E. coli?
  • [H3] ICMRA: Regulatory Collaboration Pilots
  • [H3] FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs
  • [H3] Where do SOPs need to be available?
  • [H3] What is a verified copy?
  • [H3] Which spray heads can be used in CIP systems?
  • [H3] PIC/S: What’s planned in terms of GMP?
  • [H3] How is process validation differentiated from other elements of quality management?
  • [H3] What four phases should the development of a cleaning process ideally go through?
  • [H3] Swissmedic: Standalone Regulations for In vitro Diagnostic Medical Devices
  • [H3] EMA: Updated Q&A on Nitrosamines and Step 2-Template
  • [H3] What types of CIP systems are used in practice?
  • [H3] EC: IVDR for In-vitro-Diagnostic Medical Devices Entered into Force
  • [H3] EMA: Final Guideline on Quality of Herbal Products
  • [H3] Import of Medicinal Products – Clarifications in Annex 21
  • [H3] What formal aspects help to improve the readability of SOPs?
  • [H3] FDA: Revised Guideline on OOS Results
  • [H3] ICH: Final Q3D (R2) Guideline on Elemental Impurities
  • [H3] EMA: Public Consultation on Remote Batch Certification
  • [H3] Which parameters determine the result of cleaning according to Sinner's circle?
  • [H3] EMA: Updating of Good Clinical Practice Annexes
  • [H3] MDCG: Guidance on transitional provision of IVDR
  • [H3] Initial Classification of a Commercial Return (CR) by the CR Coordinator
  • [H3] What has to be considered in risk management?
  • [H3] PMDA: English version of the global principles for clinical trials revised
  • [H3] EMA: Updated Q&A on Parallel Distribution
  • [H3] EMA: Comments on the current ICH guideline Q9 (R1) quality risk management
  • [H3] To whom are SOPs addressed?
  • [H3] CAPA Systems: Autonomous or Integrated?
  • [H3] What is a true copy?
  • [H3] GMP/GDP IWG Annual Report 2021
  • [H3] Which categories of documents do the EU GMP Guidelines identify?
  • [H3] FDA asks for feedback on streamlined "Quality-Metrics" program
  • [H3] Japanese Pharmacopeia with English Translation
  • [H3] Risk Analysis in the Equipment Life Cycle
  • [H3] TGA: Medicinal cannabis quality rules updated
  • [H3] MDCG: IVDR-implementation and preparedness plan
  • [H3] What are the 6 different types of Excel applications?
  • [H3] What must the data owner ensure regarding data archiving?
  • [H3] ICH: Draft Guidelines ICH Q14 und Q2(R2) published
  • [H3] 13 GMP Requirements for Excipient Manufacturers
  • [H3] From what stage in the chemical manufacturing process do GMP regulations apply?
  • [H3] What is the function of metadata for document management?
  • [H3] Update on Publication Date of EU Annex 1 at the ISPE Conference.
  • [H3] Deviation Causes as KPIs – Collection vs. Assessment
  • [H3] How do files and dossiers differ from each other?
  • [H3] EMA: Concept Paper on Agriculture of Herbal Drugs, GMP versus GACP
  • [H3] Swissmedic: Validity of GMP certificates during COVID
  • [H3] What types of impurities may be present in chemical active substances?
  • [H3] IPEC: Position Paper on Nitrosamine Risks in Excipients
  • [H3] Comparison of Cleaning Processes
  • [H3] What elements should be contained in a validation plan for Excel spreadsheets?
  • [H3] FDA: Proposal to align ISO 13485 with 21 CFR Parts 4 and 820
  • [H3] EC: Final Annex 21 on Importation of Medicinal Products
  • [H3] What is meant by archiving?
  • [H3] FDA: CDER Guidance Agenda for 2022
  • [H3] FDA: Robert Califf confirmed as FDA’s Commissioner in narrow vote
  • [H3] Nitrosamines: Authorities‘ Expectations and Typical Mistakes
  • [H3] What is an ASMF?
  • [H3] EMA: Q&A on nitrosamines revised on risk of multiple impurities
  • [H3] EC: Regulation (EU) 2019/6 and GDP-regulations on veterinary medicinal products in force
  • [H3] What are the requirements for advanced electronic signatures?
  • [H3] PIC/S: Revision of GMP Guide Annex 13 and new Annex 16
  • [H3] EU: EU Clinical Trials Regulation and new Information System finally in place
  • [H3] 9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises
  • [H3] What is an API Starting Material?
  • [H3] EMA: Paper on GMP Responsibilities and MAHs in Version 2
  • [H3] What is meant by registration or authorisation batches?
  • [H3] FDA: Hold on Inspections
  • [H3] Update on Annex 1 of the EU GMP Guide
  • [H3] What are the 3 designs for counterfeit-proof features?
  • [H3] Amendment of Delegated Regulation (EU) on Safety Features
  • [H3] The GMP Regulations Report 2021
  • [H3] What is a stability commitment?
  • [H3] EC: Updated Q&A on Safety Features, Version 19
  • [H3] What is the official document containing official actions sent by the FDA after a GMP inspection called? (2022)
  • [H3] EMA: ICH Q9 on Quality Risk Management in Step 2b
  • [H3] What is an end-to-end verification system?
  • [H3] ICMRA: Authorities summarise global experiences on remote inspections
  • [H3] TGA: Hybrid and remote GMP-inspections
  • [H3] What is the purpose of stability testing?
  • [H3] EMA: Overview on comments on drug device guidance
  • [H3] Swissmedic: Registration required for medical product manufacturers
  • [H3] Original Data and True Copies
  • [H3] What are the 3 main types of safety features against counterfeit medicines?
  • [H3] USP: New General Chapter 1469 on Nitrosamine Impurities
  • [H3] EU: Implementing regulation on EUDAMED published
  • [H3] Supplier Qualification: Pre-Selection Process
  • [H3] What is the FDA inspection report being called?
  • [H3] EMA: Revision of Q&A on pre-authorisation of centralised procedures
  • [H3] Process Models for the Validation of Excel Applications
  • [H3] FDA: President Biden nominates Dr. Robert Califf for FDA commissioner
  • [H3] EU GMP Guide: New concept papers for revision of Annex 4 and Annex 5 for VMPs
  • [H3] EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines
  • [H3] Responsible Person according to GDP at the Logistics Service Provider
  • [H3] EC: Mandate for strategic approach on pharmaceuticals and environment
  • [H3] TGA continues use of remote inspections
  • [H3] Cleanrooms: The Path from Concept to Qualified System
  • [H3] EU: Procedures on Inspections and Exchange of Information in new Version 18
  • [H3] Smart Deviation Management – Vision or Reality?
  • [H3] FDA/CDRH: Proposed Guidances for FY 2022
  • [H3] US, Canada, and UK issue joint principles on Good Machine Learning Practice
  • [H3] Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview
  • [H3] What is an Establishment Inspection Report (EIR)?
  • [H3] FDA: Inspectional Observations 2021 published
  • [H3] Non-Sterile Drug Products: Microbial Risks
  • [H3] What is a computerised system?
  • [H3] USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published
  • [H3] EC: Proposal for progressive introduction of IVDR
  • [H3] EMA: Q&A on Nitrosamines Updated October
  • [H3] Packaging Material Testing: The Role of Your Suppliers
  • [H3] What are the most important QMS areas of a GMP inspection?
  • [H3] PIC/S: China applies for PIC/S accession
  • [H3] What’s new for ICH Q9 and ICH Q12?
  • [H3] What is IT governance?
  • [H3] EMA: Validity of GMP and GDP certificates extended
  • [H3] EDQM: Mutagenic azido impurities in Losartan
  • [H3] EUDRAGMDP: EMA with important information for all users
  • [H3] Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?
  • [H3] What is meant by offshoring?
  • [H3] FDA: Revised Q&A on Biosimilar Development
  • [H3] EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features
  • [H3] When is a for-cause audit required?
  • [H3] Final draft of new USP chapter 1083 Supplier Qualification
  • [H3] Process Development as the Basis for Process Validation
  • [H3] What are the phases in the lifecycle of the supplier relationship?
  • [H3] EDQM: New chapter on balances in the European Pharmacopoeia
  • [H3] Test interval for integrity testing of HEPA filters in a laminar flow above an injection moulding machine
  • [H3] EDQM: Guidance for electronic submissions of CEP applications revised
  • [H3] What is a third-party audit?
  • [H3] IT Service Providers: Service Level Agreement
  • [H3] What is the goal of supplier qualification?
  • [H3] MDCG: Guidance on repackaging and relabeling processes of devices
  • [H3] WHO publishes draft documents on medicinal gases, IPs and development facilities
  • [H3] Stability Studies During the Authorisation Phase of Medicinal Products
  • [H3] What is the purpose of a qualification audit?
  • [H3] EMA: Draft Guidance on SmPC for ATMPs with Gene-modified Cells
  • [H3] EMA: Guideline on quality documentation for combination products
  • [H3] What is a shared audit?
  • [H3] What is pharmacovigilance?
  • [H3] EMA: Paper on GMP Responsibilities and MAHs
  • [H3] Remote, Distance, Offsite or Virtual Audits?
  • [H3] What is RAN and what is its purpose?
  • [H3] ICH: ICH-Q13 Draft on Continuous Manufacturing released
  • [H3] Planning, Construction and Commissioning of an Isolator
  • [H3] What interfaces to other quality systems does the deviation management have?
  • [H3] FDA: Push for more authority on device shortages
  • [H3] PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19
  • [H3] PIC/S: Final Recommendation Document on Risk-Based Change Management
  • [H3] Practical implementation of the PQS
  • [H3] What is the European safety referral used for?
  • [H3] EC: Kiwa Cermet Italia S.P.A. becomes 21st Notified Body
  • [H3] GMP Inspections: Organisation of the Front and Back Office
  • [H3] How are deviations defined?
  • [H3] EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR
  • [H3] PIC/S: Final Guideline on Data Management and Integrity
  • [H3] EMA: Revised Q&A on assessment of nitrosamine impurities
  • [H3] Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices
  • [H3] What is the purpose of line clearance?
  • [H3] EC:Updated Version 18B of Q&A on Safety Features
  • [H3] IVDR: Netherlands' DEKRA designated fifth Notified Body
  • [H3] Alternative Approach to Risk Assessment of Computerised Systems
  • [H3] What is the purpose of bulk filling inspection on the packaging line?
  • [H3] PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release
  • [H3] Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms
  • [H3] What significance do OEBs have?
  • [H3] FDA presents first global forum for generics
  • [H3] EMA: Annual Report 2020 published
  • [H3] GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)
  • [H3] What task do code readers have on a packaging line?
  • [H3] Operation PANGEA XIV: Worldwide week of action against criminal online trade in medicines
  • [H3] EMA: Updated guidance documents on parallel distribution
  • [H3] Requirements for Balances Used in Pharmaceutical Production
  • [H3] What is an OEL value?
  • [H3] CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.
  • [H3] FDA: Two new guidelines on supply chain security
  • [H3] Design Qualification for Premises and Air Handling Units
  • [H3] What does line clearance mean?
  • [H3] EC: EU MDR in force along with Q&A
  • [H3] Switzerland, EU-MDR und a missing MRA
  • [H3] Contract Manufacturing: Technology Transfer Phases
  • [H3] Swissmedic: First agreement on close cooperation with German Federal Office of Consumer Protection and Food Safety (BVL) for veterinary medicinal products
  • [H3] For what purposes are insulators used?
  • [H3] MHRA launches its own GMDP database
  • [H3] FDA: Update on remote inspections guidance and future roadmap
  • [H3] Survey of Qualified Persons on Remote Certification
  • [H3] Which GMP inspection types can be distinguished?
  • [H3] Importance of Supplier Qualification Status
  • [H3] What are the powers of the GMP inspectors in inspections?
  • [H3] ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs
  • [H3] What is confirmed by the written confirmation for imported APIs?
  • [H3] European Safety Referral: Short and Crisp
  • [H3] PIC/S: Revision of the PIC/S GMP Guide PE 009-15
  • [H3] What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?
  • [H3] Innovations in Pharmaceutical Manufacturing
  • [H3] What is the purpose of a general GMP inspection?
  • [H3] FDA:New Guidance on remote interactive inspections
  • [H3] Swissmedic: Harmonization of requirements on nitrosamines with EU
  • [H3] FDA: Patrizia Cavazzoni, M.D., to lead CDER
  • [H3] Specifications for packaging materials
  • [H3] What are the steps of an inspection procedure?
  • [H3] Export to UK: Exemption for Wholesalers
  • [H3] In which countries do the GMP rules for active ingredients according to ICH Q7 apply?
  • [H3] GMP Risk Analysis in Qualification
  • [H3] What activities does the distribution of active ingredients involve?
  • [H3] EMA: PDE for chlorobutanol as excipient reviewed
  • [H3] EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol
  • [H3] MHRA to pick up on-site inspections by end of March
  • [H3] Data Integrity in the Quality Control Laboratory
  • [H3] What should you bear in mind when maintaining rooms?
  • [H3] MDCG: Guidance on custom-made medical devices according to MDR
  • [H3] Insufficient traceability of the batch documentation
  • [H3] What is important for the processing of deviations?
  • [H3] Swissmedic: Data on imports of illegal medicinal products via the internet
  • [H3] MHRA and EU: Medicinal products in Northern Ireland
  • [H3] Rouging When Stainless Steel Corrodes
  • [H3] WHO/IAEA: Draft Guidance on GMP for Investigational Radiopharmaceutical Products
  • [H3] Which metrics should be looked at when reviewing the status of a site?
  • [H3] EDQM: Revision of Certification of Suitability for a Sartan monograph
  • [H3] The GMP Regulations Report 2020
  • [H3] How are self-inspections documented?
  • [H3] EMA: Update on recommendations for handling nitrosamines
  • [H3] EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately
  • [H3] 3 Systems for Cleanroom Walls
  • [H3] EUDAMED: Management of legacy devices
  • [H3] FDA: Revision of Nitrosamine Guidance and extension of timeframe for risk assessments
  • [H3] Swissmedic: Permanent participation in "Orbis"
  • [H3] What does a company that has incorporated a proactive compliance program look like?
  • [H3] WHO: Draft Guideline on Medical Gases
  • [H3] EC: Italian Istituto Superiore di Sanità becomes 19. Notified Body
  • [H3] EMA Guideline on the Quality of Water for Pharmaceutical Use
  • [H3] What are the advantages of using Ultrafiltration?
  • [H3] EMA: GMP requirements for herbal extracts during early manufacturing steps
  • [H3] EMA: Manufacturers to test rifampicin for nitrosamine impurities
  • [H3] How do you determine the frequency of self-inspections?
  • [H3] PIC/S: Jordan applies for membership
  • [H3] EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19
  • [H3] 2 Approaches for Implementing ICH Q3D
  • [H3] What is the difference between an EU regulation and an EU directive?
  • [H3] PMDA: Information on the procedure for remote inspections
  • [H3] FDA: CDER agenda of all guidance documents planned for 2021
  • [H3] TOP 15 Countdown: "Question of the Week"
  • [H3] What is an excipient?
  • [H3] PICS/S: Four Aide-Mémoires updated
  • [H3] FDA: Janet Woodcock becomes acting commissioner
  • [H3] Mutual recognition of inspections under the EU-UK Trade Agreement
  • [H3] 26th PTS GMP Conference – Current Topics Presented Virtually
  • [H3] Who developed the fishbone diagram?
  • [H3] PIC/S: Russia applies for membership
  • [H3] EC: Members appointed to MDR/IVDR expert panels
  • [H3] EC allows remote audits by notified bodies
  • [H3] MHRA: UK and Canada – mutual recognition of GMP and batch testing certificates
  • [H3] Brexit: The transition phase is over - MHRA publishes 48 documents
  • [H3] Containment in Perfection: The Isolator Technology
  • [H3] To which areas does the self-inspection refer?
  • [H3] How does ultrafiltration work?
  • [H3] WHO: Draft guideline on technology transfer in pharmaceutical manufacturing
  • [H3] What is an active pharmaceutical ingredient (API)?
  • [H3] Digitalised Crisis Response for Pharmaceutical Production
  • [H3] What is the purpose of self-inspections?
  • [H3] UN: Cannabis removed from Schedule IV of most dangerous drugs
  • [H3] MDCG: Q&A clarifies remote audit requirements for Notified Bodies
  • [H3] Online packaging line controls
  • [H3] How does electro-deionisation work?
  • [H3] EU unveils the Pharmaceutical Strategy for Europe
  • [H3] PIC/S: Brazilian ANVISA becomes member
  • [H3] EC: Fifth Notified Body according to IVDR
  • [H3] Brief spots on autumn conferences
  • [H3] What does reworking mean in the production of APIs?
  • [H3] Swissmedic: Clarification on the validity of GMP certificates
  • [H3] WHO: First draft guideline on GMP for research and development facilities
  • [H3] Certification of products manufactured outside the EU
  • [H3] What is a fishbone diagram used for?
  • [H3] EMA: Nitrosamine limits for active ingredients now apply to the finished products
  • [H3] WHO: New draft on GMP for investigational products
  • [H3] EMA: Emer Cooke takes over leadership position
  • [H3] Insufficient cleaning validation
  • [H3] How do you ensure the traceability of the batch documentation?
  • [H3] Nitrosamine risk evaluation: Switzerland follows EU deadline extension
  • [H3] Can the author of a GMP document also act as its reviewer?
  • [H3] What does reprocessing mean in the production of APIs? (2020)
  • [H3] Swissmedic: Adaptions to inspection routine due to Covid-19
  • [H3] Criticality classifications of deviations
  • [H3] What are the pros and cons when using UV irradiation in water pre-treatment systems?
  • [H3] EMA: Implementation plan to reduce nitrosamine impurities
  • [H3] What is the point of "heating" medicinal products to 15–25 °C?
  • [H3] What is an informal QRM method?
  • [H3] EC: New webpage to Actor Registration Module for EUDAMED
  • [H3] EMA calls for nitrosamine testing of metformin-containing drugs
  • [H3] Thoughts on the transport of pharmaceuticals from a claims handling perspective
  • [H3] Which two factors are particularly important for a GMP-compliant process validation?
  • [H3] British MHRA becomes new member of the ACSS Consortium
  • [H3] Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?
  • [H3] How does a risk assessment work?
  • [H3] Regulatory Compliance - Issue Identification
  • [H3] How can UV irradiation be used in pharmaceutical water generation?
  • [H3] ICH: Q3D(R2) for elemental impurities reaches Step 2
  • [H3] EMA reports extension of deadline for nitrosamine risk assessment
  • [H3] Optimum GMP training concept: modular and inclusive e-learning
  • [H3] What role does quality risk management play in the quality management system?
  • [H3] Swissmedic: Warning from Brazil due to counterfeit medicinal products from Turkish wholesalers
  • [H3] CHMP confirms recommendation on ranitidine medicines
  • [H3] ICH Update Quality Initiatives
  • [H3] In which phases is the quality risk management process divided?
  • [H3] Now published: EN 17141:2020 Cleanrooms and associated controlled environments – biocontamination control
  • [H3] Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample
  • [H3] What are the requirements for successful quality risk management (QRM)?
  • [H3] Sliding doors in cleanrooms - "no go" or "best practice"?
  • [H3] Swissmedic: On-site inspections on a regular basis again
  • [H3] What are complexing agents and how do they work?
  • [H3] FDA: Comprehensive Guidance on Control of Nitrosamine Impurities
  • [H3] MHRA publishes numerous guidelines for post-brexit period
  • [H3] Inadequate handling of deviations: the cause "human error"
  • [H3] What are the advantages and benefits of quality risk management (QRM)?
  • [H3] FDA: Q&A for the manufacture of drugs and biological products, their supply chain and inspections during COVID-19
  • [H3] EC: Updated version 18 of Q&A on safety features for medicinal products for human use
  • [H3] What is a residual risk?
  • [H3] MHRA inspections: Deficiencies and expectations on HBELs and cross contaminations – PIC/S AiM and Q&A provide answers
  • [H3] What has to be considered for risk management?
  • [H3] MHRA: Risk-based resumption of on-site inspections in September
  • [H3] WHO: Three new draft guidelines published
  • [H3] Why is the use of activated carbon filters critical as a pre-treatment process?
  • [H3] EMA: MRA partners may participate in JAP audits as co-auditors
  • [H3] EMA: New Q&A on nitrosamine impurities for marketing authorisation holders
  • [H3] How do you organize GMP knowledge and relevant news in your organization?
  • [H3] What is a risk?
  • [H3] Two different pairs of boots: GMP for APIs and GMP for medicinal products
  • [H3] What is hygienic design?
  • [H3] EMA: Final Assessment Report on Nitrosamines
  • [H3] EMA: New guideline on the quality of water for pharmaceutical use
  • [H3] Filter integrity test
  • [H3] What is an action limit, and what happens when it is exceeded?
  • [H3] Switzerland: New MepV and KlinV-Mep adopted
  • [H3] Substance-based medical devices
  • [H3] Why has drinking water to be pretreated when using it for pharmaceutical water production?
  • [H3] French GMED becomes 15th Notified Body under MDR
  • [H3] New EMA Executive Director: Emer Cooke from Ireland
  • [H3] Ask our Experts GMP-compliant documentation: Handling of glued-in printouts
  • [H3] What is commissioning?
  • [H3] EMA and Korean MFDS share confidential COVID-19 information
  • [H3] EMA: Further update of Q&A on regulatory GMP-requirements during COVID-19
  • [H3] Work instructions, records and documentation
  • [H3] What is monitoring?
  • [H3] Nitrosamines: Lessons learnt from sartan medicines
  • [H3] Hygienic design of pharmaceutical manufacturing processes - example: tablet press
  • [H3] What is metrology?
  • [H3] TÜV SÜD Product Service becomes fourth Notified Body under IVDR
  • [H3] WHO: Three new draft guidelines for commentary
  • [H3] GMP:READY: GMP for Engineers
  • [H3] What phases are involved in planning a construction project?
  • [H3] What does official calibration mean?
  • [H3] FMD alerts in 2020 – where we are a year into legislation
  • [H3] PIC/S publishes two new documents on HBELs
  • [H3] EC presents concept for the supply of medicinal products for comment
  • [H3] What is an alert limit, and what happens when it is exceeded?
  • [H3] EMA: Update of Q&A on flexible regulatory GMP/GDP requirements during COVID-19
  • [H3] WHO publishes Technical Report Series No. 1025, 2020
  • [H3] Environmental Risk Assessment: ERA Reports
  • [H3]
  • [H3] What is meant by adjustment?
  • [H3] MDR: Intertek from Sweden becomes 14th notified body
  • [H3] Purpose and content of a management review
  • [H3] What types of requalification are distinguished?
  • [H3] US FDA: Gradual restart of surveillance inspections
  • [H3] EU GMP: Consultation Deadline for Annex 21 Extended to August
  • [H3] Challenges Lurking in Manufacturing
  • [H3] What does calibration mean?
  • [H3] EMA: Suspension of ranitidine medicines
  • [H3] 12 FREQUENTLY ASKED QUESTIONS on SOPs
  • [H3] EU GMP: Consultation Deadline for Annex 1 Extended to July
  • [H3] What is confirmed by an ATP certificate?
  • [H3] CMDh: Decentralised procedures and mutual recognition during COVID-19
  • [H3] Nothing ventured, nothing gained
  • [H3] What is meant by measurement chain?
  • [H3] British MHRA temporarily relaxes GMP regulation
  • [H3] EU MDR: Decision on delay by one year
  • [H3] Disruptive technologies in the production of pharmaceuticals
  • [H3] What data is monitored when monitoring a HVAC system?
  • [H3] Batch Designation: Handwritten or Electronic?
  • [H3] EMA and COVID-19: Task Force and Q&A on flexible regulatory requirements for pharmaceutical companies
  • [H3] MDR and ICH Q12: Switzerland's adaptation to the EU
  • [H3] Which criteria shoud be used for the selection of insulated transport boxes?
  • [H3] EC: New ways to conduct Notified Body-audits during COVID-19
  • [H3] Acceptance testing or qualification?
  • [H3] ICH publishes ICH Q3C(R8) with three new PDES for comments
  • [H3] What is the purpose of a measurement point risk analysis?
  • [H3] The QP should decide or "lessons learned"
  • [H3] MDR: Proposal for a delay due to Covid-19
  • [H3] What is meant by cleanroom equipment?
  • [H3] Draft of EU-GMP Annex 21: Import of medicinal products published
  • [H3] Extended deadline for risk assessment of nitrosamine impurities
  • [H3] Updated version 17 of the Q&A on safety features for medicinal products for human use
  • [H3] GMP training courses in the online offline tension field
  • [H3] Which key aspects should be addressed when defining the requirements profile of a logistics service provider?
  • [H3] Australian TGA Suspends Overseas GMP Inspections
  • [H3] FDA: Domestic routine inspections postponed due to Covid-19
  • [H3] The power of the comma Or: What do print data have to do with drug safety?
  • [H3] Which test is used to determine the conductivity of pharmaceutical water qualities?
  • [H3] FDA: Foreign Inspections postponed due to Coronavirus
  • [H3] Questions about manufacturing technology
  • [H3] How are medicinal products requiring cool transport conditions labeled for air freight?
  • [H3] EMA: What EU adaptations are necessary for ICH Q12?
  • [H3] India: Restricted exports of APIs due to coronavirus
  • [H3] Trust is good, calibration is better!
  • [H3] For what purposes can drinking water be used in the pharmaceutical industry?
  • [H3] The GMP Regulations Report 2019
  • [H3] Operation Broadsword: US FDA and Indian Government combat illegal drugs
  • [H3] ICH Q12: Introductory Training Presentation published
  • [H3] What guidelines and quality standards apply to airfreight?
  • [H3] EU GMP Annex 1: Second Draft on Sterile Manufacture
  • [H3] 7 Basic GMP Questions and Answers
  • [H3] Where is a qualification according to DIN Spec. 91323 applicable?
  • [H3] MDR: National Standards Authority of Ireland (NSAI) is 11th Notified Body
  • [H3] ICH: Plans to harmonize with PIC/S and WHO
  • [H3] MHRA: Feedback from GMP inspections
  • [H3] Which aspects are decisive for the performance of passive shipping containers?
  • [H3] MDR: Norwegian DNV GL Presafe AS is 10th Notified Body
  • [H3] EMA: Information on Brexit
  • [H3] Packaging material testing
  • [H3] What are the possible benefits of risk management in transportation?
  • [H3] News on our behalf: new name, new logo
  • [H3] FDA: CDER list of all guidelines planned for 2020
  • [H3] TOP 15 Countdown: “Question of the Week” 2020
  • [H3] What is meant by active and passive temperature control?
  • [H3] EMA: Reflection Paper on GMP-related responsibilities of MAHs
  • [H3] Microbiological monitoring in non-sterile areas
  • [H3] How can medicinal products requiring cool transport conditions be transported?
  • [H3] FDA approves new ISO Standard 14971:2019 for medical devices
  • [H3] Selection and procurement of cleanroom construction components
  • [H3] What are the phases of a qualification of insulated transport boxes?
  • [H3] EMA: Revised Q&A on Nitrosamine Contamination
  • [H3] EMA: Update of Q&A on EU-US MRA
  • [H3] GDP inspections: How to avoid defects
  • [H3] Where can you find concrete information regarding "transport and temperature?"
  • [H3] Your question – our answer: Environmental Monitoring
  • [H3] What is DIN Spec 91323?
  • [H3] Why is temperature a critical aspect in transportation?
  • [H3] What are the central tasks of logistics?
  • [H3] What is a training profile?
  • [H3] Which general requirement applies to the design of material locks?
  • [H3] What is a root cause?
  • [H3] What is the difference between the point of occurrence and the point of recognition of a failure?
  • [H3] What is the difference between a direct cause and a contributing cause of failure?
  • [H3] What does a challenge-concept for cleaning validation mean?
  • [H3] What is industrial hygiene?
  • [H3] Who is responsible for planning and implementing cleaning validation?
  • [H3] Which countries are covered by the British Pharmacopoeia?
  • [H3] Do European Pharmacopoeia methods need to be validated by the user?
  • [H3] What is gauging?
  • [H3] Do USP methods need to be validated by the user?
  • [H3] What is calibration?
  • [H3] What is the link between the European and the British Pharmacopoeia?
  • [H3] What does commissioning mean?
  • [H3] What is the legal status of the European Pharmacopoeia?
  • [H3] What is the objective of laboratory equipment qualification?
  • [H3] What is the Design Qualification?
  • [H3] Why is a system suitability test (SST) performed in addition to equipment qualification?
  • [H3] When is it imperative to monitor transport temperatures for finished drug products?
  • [H3] Which criteria are to be considered when selecting cleaning agents?
  • [H3] How should raw data be handled?
  • [H3] Why should OQ tests cover the entire working range of the equipment?
  • [H3] Who is responsible for generating the PQ protocols?
  • [H3] Which are the key aspects of personnel hygiene?
  • [H3] What is the difference between an EDMS and an EQMS?
  • [H3] What are the so-called safety features on packaging materials?
  • [H3] What is the advantage of a 2D-MatrixCode?
  • [H3] How can a uniform colouring of secondary packaging materials be achieved?
  • [H3] What is meant by serialisation?
  • [H3] What are print data for secondary packaging materials?
  • [H3] What is the disadvantage of a sit-over bench?
  • [H3] Is it acceptable to use a transport trolley for material transfer from one cleanliness class to another?
  • [H3] Which materials can be used for furniture and furnishings in cleanliness Grade C?
  • [H3] What are the major trends that have changed the concept of validation recently?
  • [H3] What should be considered when installing automatic sliding doors in cleanrooms?
  • [H3] Which role plays a runner during an inspection?
  • [H3] What is the difference between a bubble type and a sink type pressure cascade?
  • [H3] What is meant by the term "metadata"?
  • [H3] Is it necessary to wear gloves in cleanroom class D?
  • [H3] What is the significance of growth controls in microbiological monitoring?
  • [H3] What is the minimum requirement for cleaned equipment?
  • [H3] Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?
  • [H3] What is a training profile? (2018)
  • [H3] What is the significance of an action level?
  • [H3] Should calibration be done during IQ or as part of OQ?
  • [H3] What is the significance of an alert level?
  • [H3]
  • [H3] GMP Newsletter LOGFILE
  • [H4] GMP Compliance Adviser
  • [H4] GMP:KnowHow Pharma Logistics (GDP)
  • [H4] E-Learning GMP:READY | Specialist Knowledge GDP Compact
  • [H4] E-Learning GMP:READY | GMP for Engineers Online Course
  • [H4] Annex 1: What's new? – A Comparison from Draft to Final
  • [H4] GMP Fundamentals | A Step-by-Step Guide
  • [H4]  
  • [H4]  
  • [H4] Assessment of GxP relevance
  • [H4] The deficiency
  • [H4] The Foundational Role of Pharma R&D in the Supply Chain
  • [H4] Stay up-to-date on the latest developments in Good Manufacturing Practice.

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Sauberes HTML, eine korrekte Zeichencodierung und moderne Standards verbessern Kompatibilität, Zugänglichkeit und die zuverlässige Verarbeitung der Seite.

Doctype

HTML 5

Verschlüsselung

gmp-manual.de deklariert den Zeichensatz UTF-8. Das ist wichtig, damit Sonderzeichen, Umlaute und typografische Zeichen korrekt dargestellt werden.

W3C Validität

Fehler : 0

Warnungen : 0

E-Mail Datenschutz

gmp-manual.de sollte offen sichtbare E-Mail-Adressen absichern. Eine geschützte Darstellung verringert die Wahrscheinlichkeit automatisierter Spam-Erfassung. Mit diesem kostenlosen Werkzeug lassen sich Adressen besser schützen.

Veraltetes HTML

Veraltete Tags Vorkommen
<u> 1

gmp-manual.de enthält deprecated HTML-Markup. Eine Bereinigung kann Wartbarkeit, Validierung und technische Zukunftssicherheit verbessern.

Tipps zur Webseitengeschwindigkeit

Bei gmp-manual.de wurden keine verschachtelten Tabellen erkannt. Das ist positiv für sauberes Markup und responsive Gestaltung.
Auf gmp-manual.de wurden Inline-CSS-Angaben gefunden. Wenn möglich, sollten diese Regeln in Stylesheets verlagert werden, damit Gestaltung und Inhalt sauberer getrennt sind.
Die Anzahl der CSS-Dateien bei gmp-manual.de wirkt unkritisch. Wenige, sinnvoll gebündelte Stylesheets erleichtern die technische Optimierung.
gmp-manual.de bindet mit 8 JavaScript-Dateien nur eine begrenzte Menge Skripte ein. Das ist eine gute Grundlage für schnelle Ladezeiten.
gmp-manual.de nutzt gzip-Komprimierung. Dadurch können HTML, CSS und JavaScript kleiner übertragen werden, was die Ladezeit verbessern kann.

Mobile

Mobile Optimierung ist wichtig, weil viele Besucher Smartphones nutzen. Viewport, Icons und ungeeignete Technologien beeinflussen Darstellung und Bedienbarkeit.

Mobile Optimierung

Apple Icon
META Viewport Tag
Flash Inhalt

Optimierung

Sitemap, robots.txt, Komprimierung und Analysesysteme beeinflussen, wie effizient eine Website gecrawlt, ausgeliefert und gezielt weiterentwickelt werden kann.

XML-Sitemap

Fehlt

Für gmp-manual.de wurde keine XML-Sitemap gefunden. Eine Sitemap listet wichtige URLs und kann Suchmaschinen Hinweise zu Aktualisierung und Struktur der Website geben.

Robots.txt

http://gmp-manual.de/robots.txt

gmp-manual.de enthält eine robots.txt-Datei. Damit lassen sich Crawler-Regeln und der Hinweis auf die Sitemap zentral steuern.

Analytics

Fehlt

gmp-manual.de scheint kein Analytics-System einzusetzen. Ein datenschutzkonform eingebundenes Analyse-Tool kann helfen, Optimierungen gezielter zu planen.

PageSpeed Insights

PageSpeed Insights bewertet Leistung, Barrierefreiheit, bewährte Verfahren und SEO für Desktop und Mobilgeräte und macht technische Bremsen sichtbar.

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Website-Überprüfung

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