Blog

  1. LOGFILE No. 10/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 1

    What a Qualified Person must know about the recent cleaning validation updates – Part 1

    6 minutes reading time

    by Walid El Azab

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  2. Will the UK Be Part of EMA After Brexit? –EC and UK Follow Different Approaches

    While Theresa May promoted the benefits of the UK becoming an associate member of the EMA, the EU took quite an opposite position. In a draft guideline published on 7 March 2018 the EU sets out how the EU council sees its future with the UK. A comment by the British newspaper “The Guardian” states that while the British government does Brexit by speeches the EU prefers releasing documents.

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  3. FDA Warns OTC Drugmakers in China and Hong Kong, Drug Manufacturer in the US, Sends 483s to Aurobindo and Sun

    The US Food and Drug Administration (FDA) released two warning letters sent to over-the-counter (OTC) drugmakers in China and Hong Kong and a third one to a drug manufacturer in the USA. In addition, two Form 483s for India-based Sun Pharmaceutical Industries and Aurobindo Pharma were released.

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  4. LOGFILE No. 09/2018 – General principles of hygienic design

    General principles of hygienic design

    An excerpt from the GMP Series PDF Download Applying the Principles of Hygienic Design to Solid Dosage Forms

    8 minutes reading time

    by Richard Denk

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  5. 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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  6. MHRA: Out of Specification Guidance

    The MHRA has updated its interesting guidance on how to handle OOS results. The issue faced when dealing with “Out of Specification” results is always a challenge. Many customer requests we receive address this issue.

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  7. EU/US: MRA on Inspections – Four More Member States Added

    On 1 March 2018, the FDA listed four additional recognised authorities under Article 7 of the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs). This confirms the capability of the following four European Member States to carry out GMP inspections at a level equivalent to the US:

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  8. EMA Publishes Work Plan for the GMP/GDP Inspectors Working Group

    The European Medicines Agency EMA has published the adopted 2018 Work Plan for the GMP/GDP Inspectors Working Group. The 8-page document lists, inter alia, new guidance documents and also guidance documents to be revised within the EU GMP Guide. According to the EMA, the plan has been agreed in view of preparing for the relocation of the agency to Amsterdam and is, therefore, subject to further review and reprioritisation.

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  9. LOGFILE No. 08/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

    What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

    6 minutes reading time

    A commentary by Ruven Brandes and Fritz Röder

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  10. LOGFILE No. 07/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

    What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

    6 minutes reading time

    A commentary by Ruven Brandes and Fritz Röder

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