If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices
1. Site Master File
A Sample for Download
according to PIC/S PE 008-4!
2. Checklist GMP-Inspections
650 questions typically asked during audits
3. Process Validation
official requirements, validation planning and procedure, ...
GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries
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"The year 2008 was one of consolidation and steady progress for the European Medicines Agency (EMEA), rather than one of major leaps and bounds.
However, set against a background of continuing globalisation of the pharmaceutical sector, further rapid advances in medical science and the unrelenting pace of regulatory activity in the medicines network of the European Union (EU), it was by no means a ‘dull’ year for the Agency.
As pharmaceutical development and clinical trials of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical practices are being used for the development and testing of medicinal products in all parts of the world. In 2008, the Agency intensified its cooperation with international partners to ensure its contribution to global efforts for safer and better medicines around the world. [...]"
Source: Summary of the European Medicines Agency’s annual report for 2008, EMEA, 2009, EMEA/362115/2009
Annual report Summary (17 pages)