GMP Compliance Adviser: Updates Forecast & History

  • GMP Compliance Adviser Update No. 5/2017

    With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP Regulations

    C.10 Compilation of Community Procedures on Inspections and Exchange of Information
    C.10.1

    Conduct of Inspections of Pharmaceutical Manufacturers or Importers

    C.10.2 Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries
    C.10.3 Guideline on Training and Qualifications of GMP Inspectors
    C.10.4 Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials
    C.10.5 The Issue and Update of GMP Certificates
    C.10.6 A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers
    C.10.7 Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health
    C.10.8 Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations
    C.10.9 Guideline on Training and Qualification of Inspectors Performing Inspections of Wholesale Distributors
    C.10.10 GDP Inspection Procedure (Medicinal Products for Human Use)
    C.10.11 The Issue and Update of GDP Certificates (Medicinal Products for Human Use)

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  • GMP Compliance Adviser Update No. 4/2017 (online version only)

    With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    6.J Example SOP for the qualification of equipment and machinery
    14.N

    Data integrity in the quality control laboratory

    15.H Data integrity - general requirements in a GxP-regulated environment

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  • GMP Compliance Adviser Update No. 3/2017 (online version only)

    With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    6.E Installation Qualification (IQ)
    14.J Btach Release


    GMP Regulations

    D.1.5 21 CFR Part 4 Regulation of Combination Products
    D.25 Guidance for Industry and FDA Staff:
    Current Good Manufacturing Practice Requirements for Combination Products

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  • GMP MANUAL Update No. 2/2017 (online version only)

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    4.A Facility Planning
    4.B Materials
    13.A.8 Packaging material testing


    GMP Regulations

    D.24 Guidance for Industry:
    Contract Manufacturing Arrangements for Drugs: Quality Agreements
    H.18 WHO: Good trade and distribution practices for pharmaceutical starting materials
    (Technical Report Series, No. 996 (2016), Annex 6)

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  • GMP MANUAL Update No. 1/2017 (online version only)

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    6.D Design Qualification (DQ)
    18.I Preparing for FDA GMP inspections


    GMP Regulations

    C.21 EMA: Data Integrity Questions and Answers
    E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents

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  • GMP MANUAL Update No. 27 (online version only)

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    3.F Building Services
    6.C Qualification documentation
    7.A Official requirements and agency expectations
    7.D Validation documentation
    9.H Validation of Excel applications
    11.G Weighing
    18.F Self-inspection


    GMP Regulations

    C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use, Q&A, Version 7
    D.1.6 21 CFR 600
    D.1.7 21 CFR 606
    D.1.8 21 CFR 680
    D.1.9 21 CFR 601
    D.23 Submission of Quality Metrics Data, Revision 1, DRAFT
    D.23.1 Quality Metrics Technical Conformance Guide, Version 1.0, DRAFT

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  • GMP MANUAL Update No. 26

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:


    GMP in Practice

    5.D Qualification of water supply systems
    6.A Official requirements and agency expectations
    6.B Activities for the preparation of a qualification
    6.H The qualification lifecycle (NEW)
    6.I Validation by third party (NEW)
    8.E Establishment of limits
    18.H Questionnaire for preparing GMP-inspections


    GMP Regulations

    D.1.1 CFR 210
    D.1.2 CFR 211
    D.1.3 CFR 11
    D.1.4 CFR 820
    D.1.5 CFR 4
    H.8 WHO GMP practices for biological products, WHO TRS No. 996, 2016
    H.11 WHO Guideline on GMP: validation, Appendix 7: non-sterile process validation Annex 3, WHO TRS 992, 2015
    H.17 WHO Guidance on good data and record management practices
     

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  • GMP MANUAL Update No. 25

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:


    GMP in Practice

    5.F Pure Steam Systems
    5.G Monitoring Pharmaceutical Water
    7.B Validation – a key element in a QM system
    7.C Organisation, planning and implementation
    14.A Sampling
    17.B Contract Analysis


    GMP Regulations

    C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use Q&A Version 6
    D.1.8 21 CFR 680
    D.1.9 21 CFR 601
    D.20 Quality Considerations in Demonstrating Biosimilarity
    D.21 Biosimilars: Q&A
    D.22 Data Integrity and Compliance with CGMP, DRAFT
     

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  • GMP MANUAL Update No. 24

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:


    GMP in Practice

    3.H Pharmaceutical gases
    11.H Labelling
    11.I In-Process controls
    11.K Rework
    14.I Documentation in the laboratory
    14.K Microbiological testing
    19.L Management review
    24.A Storage
    24.B Storage areas
    24.C Storage conditions
    24.D Incoming goods


    GMP Regulations

    C.6.16 Annex 16: Certification by a
    Qualified Person and Batch Release
    C.6.17.1 Annex 17 Draft: Real Time Release Testing
    D.1 Code of Federal Regulations
    D.1.1 21 CFR Part 210
    D.1.2 21 CFR Part 211
    D.1.3 21 CFR Part 11
    D.1.4 21 CFR Part 820
    D.1.5 21 CFR Part 4
    D.1.6 21 CFR Part 600
    D.1.7 21 CFR Part 606
    D.19 Guidance for Industry: Scientific Considerations in
    Demonstrating Biosimilarity to a Reference Product
     

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  • GMP MANUAL Update No. 23

    With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

    GMP in Practice

    3.A Official requirements
    5.C Distribution and storage of pharmaceutical water
    5.E Operation of water supplies
    11.F GMP in the production process
    11.J Prevention of cross-contamination
    14.G Stability Testing

    GMP Regulations

    C.5 EU GMP Guidelines, Part II – combined with APIC How to do (Version August 2015)
    C.20 Guidelines on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use
    E.7.1 ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – Questions and Answers
    H.11 Supplementary Guidelines on GMP: Validation, Appendix 7: Non-sterile Process Validation (TRS No. 986, 2014)
    H.15.1 Technical Supplements to Model Guidance for the Storage and Transport of Time- and Temperature-sensitive Pharmaceutical Products (TRS No. 992, 2015, Annex 5 und 11 Supplements)
    H.16 General Guidance on Hold-time Studies (TRS No. 992, 2015, Annex 4)
     

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