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The revised Chapter 4 Documentation (see our GMP News) of the EU GMP Guide will come into force on 30 June 2011. More detailed documentation on transfers is one of the new requirements. Among others, new requirements have been added to Chapter 4.29 concerning SOPs on technology transfer, transfer protocols and reports. Even the Aide Mémoire of the ZLG (German Central Authority for Health Protection) about "Inspection on Qualification and Validation in the pharmaceutical manufacture and quality control" which was revised in 2010 now includes requirements on process and method transfers. Chapter 8.3 describes the aspects which indicate the risks-based scope of validation activities during a transfer. Important points are the qualification status of the previous production sites, changes which are made during the transfer, process robustness and understanding as well as new risks, which may arise at the accepting site during a transfer e.g. new cross contamination risks. Find further information in the of the EU GMP Guide Chapter 4 as well as in the ZLG document (only available in German though). Author:
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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