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Manufacture of Sterile Medicinal Products: ‘Annex 1’ - DRAFT

Manufacture of Sterile Medicinal Products: ‘Annex 1’ - DRAFT. new. Dr.-Ing. Stephan Roenninger Amgen (Europe) GmbH Director, External Affairs. GMP According to Annex 1 Applies for Manufacture of Drug (medicinal) Products. Annex 1. GMP-Part I. GMP-Part II (ICH Q7). Drug (medicinal) Product.

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Manufacture of Sterile Medicinal Products: ‘Annex 1’ - DRAFT

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  1. Manufacture of Sterile Medicinal Products: ‘Annex 1’ - DRAFT new Dr.-Ing. Stephan Roenninger Amgen (Europe) GmbHDirector, External Affairs

  2. GMP According to Annex 1 Applies for Manufacture of Drug (medicinal) Products Annex 1 GMP-Part I GMP-Part II (ICH Q7) Drug (medicinal)Product FinishedProduct Raw Material API starting material Patient API Sterile Manufacturing New structure & Size 16 pages -> 50 pages; Covers terminally sterilized products, aseptic preparation, the variations of sterilization including filtration and finishing of sterile products and the variations of sterilization including filtration new Annex 1 draft, Chapter 1

  3. Principle: Minimize Risks of Microbiological, Particulate and Pyrogen Contamination – Contamination Control Strategy new Regulatory filingManufacturing Process and IPC testing is approved new new Dossier & GMP Annex 1 draft, Chapter 2,4

  4. Different Equipment Exists and Can be Operated in Compliance Design and qualification requirements for Premises, Equipment and Utilities (water, air and vacuum) are described – Barrier technology new • Required equipment and/or other materials that may come into contact with a product or influence it directly • Water systems • Steam used for sterilization • Compressed gas and vacuum • Cooling systems new Glove-Box • Clean room classifications (ISO 14644) and their qualification • Measure particles equal to or greater than 0.5 μm • Maintained in recommended limits for the monitoring of non-living particles conventional line RABS-Unit PDA letter, June 2019, p.34; based on the PDA research Survey 2017. new Annex 1 draft, Chapter 5, 6, 7

  5. The Pharmaceutical Quality System (PQS) Need to Have Additional Controls and Measures to Ensure Quality: QRM to Prevent Contamination Basics Sufficient knowledge and expertise Root Cause Analysis and CAPA Quality release Effective Quality Risk Management System new Annex 1 draft, Chapter 3

  6. Integrated Risk-based Controls of Microbial Contamination From Raw Material Until the Final Product Release Examples Raw Materials Facility Process Controls DP Testing • Endotoxin • Sterility • Annual Stability Program • Campaign post process Environmental Monitoring • Media Hold Validation • Engineering controls tested per lot • Environmental Monitoring Program • Media Fill and Airflow Visualization Study - Pest Control - Facility Cleaning and sanitization - Gowning - Clean Utilities - Material Flow and Cleaning - Supplier Qualification Program - Raw Material Controls

  7. Annex 1 Lists ‘How to Do’ Requirements for Production and Specific Technologies • Quality Control • Testing is only the last step in a series of control measures • Representative samples Bioburden assay on each batch • Environmental monitoring data part of batch record • Rapid microbial methods new new new Annex 1 draft, Chapter 8, 9, 10

  8. QRM: Protecting Patients can Follow a Holistic View Taking into Account Elements Described in Different Documents • Guidance documents are intended to be read in its entirety regardless of the nature of the activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate GMPs at all stages of the supply chain. • According to the ICH Q7-IWG Q&A QRM: Quality Risk Management Aknowledgement: Elizabeth Meyers, Myrta Atiles and Kris Evens, Enid Marin-Vallejo Amgen & Gabriele Gori, GSK

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