1. FDA Warning Letters go to Manufacturers in China, Ireland, Australia and India

    In May the US FDA has issued five Warning Letters that address cGMP-violations on a large scale. The drug facilities involved are:

    • Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
    • Jalco Cosmetics, Australia
    • Europharma Concepts, Ireland
    • Reine Lifescience, India.

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  2. EMA: Draft Guideline on Handling and Shipping of IMPs according to GMP

    On 23 May 2018, the European Medicines Agency (EMA) released a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs) for public consultation.

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  3. LOGFILE No. 20/2018 – Practical Issues on Supply Chain and Good Distribution Practice

    Practical Issues on Supply Chain and Good Distribution Practice

    A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

    6 minutes reading time

    by Susanne Sailer

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  4. Post-Brexit Agreement for UK's Pharmaceutical Industry Needed

    The UK government must secure a post-Brexit deal for the pharmaceutical industry that ensures the closest possible regulatory alignment with the EU and the minimum border friction possible or risk harming patients and seeing the pharma sector losing its status as a world leader, say the Business, Energy and Industrial Strategy Committee of the UK parliament.

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  5. 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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  6. LOGFILE No. 19/2018 – 2017 - The GMP Regulations Report

    2017 – The GMP Regulations Report

    by Sabine Rabus

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  7. Danish-Japanese collaboration – FDA Confidentiality Commitment

    The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.

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  8. PIC/S Meeting in April 2018

    From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

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  9. LOGFILE No. 18/2018 – The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

    The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

    A report on the ISPE European Annual Meeting 2018

    8 minutes reading time

    by Thomas Peither

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  10. LOGFILE No. 17/2018 – Layout of a Cleanroom Air Handling Unit

    Layout of a Cleanroom Air Handling Unit

    An excerpt from the GMP Compliance Adviser, Chapter 3.I Air Handling Technology

    6 minutes reading time

    by Harald Flechl

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