GMP Compliance Adviser: Updates Forecast & History

  • GMP Compliance Adviser Update No. 4/2018

    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

    14.N Determining and reporting numerical test results in pharmaceutical quality control
    15.D Standard Operating Procedures (SOPs)


    GMP Regulations

    C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide
    C.8.6.1 Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting healthbased exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/ SWP/169430/2012)

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  • GMP Compliance Adviser Update No. 3/2018

    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

    3.I Air Handling Technology

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  • GMP Compliance Adviser Update No. 2/2018

    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.F Operational Qualification (OQ)
    6.G Performance Qualification (PQ)


    GMP Regulations

    E.12 Draft Version ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

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  • GMP Compliance Adviser Update No. 1/2018

    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.6.1.1 Annex 1 – Draft: Manufacture of Sterile Medicinal Products
    C.22 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
    D.26 Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

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  • GMP Compliance Adviser Update No. 10/2017

    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 in Practice

    11.C Production hygiene
    11.D Hygiene plan

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  • GMP Compliance Adviser Update No. 9/2017

    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 in Practice

    11.A Industrial Hygiene
    11.B Personnel Hygiene

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  • GMP Compliance Adviser Update No. 8/2017

    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 in Practice

    14.D Laboratory Instruments


    GMP Regulations

    E.11.1 ICH Q11: Q&A
    Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

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  • GMP Compliance Adviser Update No. 7/2017

    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 in Practice

    20.E Failure Management


    GMP Regulations

    GMP Glossary updated
    D.1.1

    21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

    D.1.2 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
    D.1.3 21 CFR Part 11 Electronic Records; Electronic Signatures
    D.1.4 21 CFR Part 820 Quality System Regulation
    D.1.5 21 CFR Part 4 Regulation of Combination Products
    D.1.6 21 CFR Part 600 Biological Products: General
    D.1.7 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
    D.1.8 21 CFR Part 680 Additional Standards for Miscellaneous Products
    D.1.9 21 CFR Part 601 Licensing

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  • GMP MANUAL Update No. 7/2017 (online)

    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

    20.E Failure Management


    GMP Regulations

    GMP Glossary updated
    D.1.1

    21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

    D.1.2 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
    D.1.3 21 CFR Part 11 Electronic Records; Electronic Signatures
    D.1.4 21 CFR Part 820 Quality System Regulation
    D.1.5 21 CFR Part 4 Regulation of Combination Products
    D.1.6 21 CFR Part 600 Biological Products: General
    D.1.7 21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
    D.1.8 21 CFR Part 680 Additional Standards for Miscellaneous Products
    D.1.9 21 CFR Part 601 Licensing

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  • GMP Compliance Adviser Update No. 6/2017

    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 in Practice

    8.A Official requirements and agency expectations


    GMP Regulations

    C.5 EU GMP Guide Part II:
    Basic Requirements for Active Substances used as Starting Materials
    combined with GMP for APIs:
    “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide

    Read more
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