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 paper describes the current situation with an increasing number of inspections by 34 inspectorates in the last years.
To raise awareness, EFPIA has collected data annually through surveys of EFPIA member companies since 2003. The data demonstrates that immense resources are spent on preparation, hosting and follow up activities. Member companies used an average of 130 industry man-days per GMP inspection.
EFPIA Position Paper "GMP - Inspections of Global Pharmaceutical Supply Chains"
Source: EFPIA (www.efpia.org)