Then you need to have a Site Master File that is in compliance with the EU regulation framework.
Make the preparing of your SMF easier and use our new e-book: A sample Site Master File created for Maas & Peither Pharma GmbH as a virtual company.
- incl. useful comments on the separate sections
- according to PIC/S PE 008-4
After PIC/S published the new document PE 008-4 at the end of 2010/start of 2011 on their website, the corresponding, virtually identical Directive of the European Commission was published in February 2011 for information purposes as the first document in the new Part III of the EU-GMP Guidelines. This was followed in January 2011 by the publication of the revised Chapter 4 of the guidelines. The Site Master File is listed there as one of the compulsory quality documents for pharmaceutical manufacturers; all pharmaceutical manufacturers are now obliged to maintain a Site Master File.
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