Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Stay informed!
If you’d like to be regularly informed of the latest developments at Good Manufacturing Practices
GMP Subject Downloads
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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News about GMP/cGMP
EMA FAQ on GMP Topics
From time to time EMA (EMEA) publishes the answers to frequently asked questions following discussion and agreement of the GMP/GDP Inspectors Working Group and they are published on this page.
There are four topics of questions and answers, covering several subitems:
- EU GMP Guide Part I Basic Requirements for Medicinal Products
- Chapter 5 Qualification of suppliers - EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials
- GMP compliance for Active Substances
- GMP compliance for Active Substances in IMPs - EU GMP Guide Annexes - Supplementary Requirements
- Annex 1 Manufacture of Sterile Medicinal Products
- Annex 8 Sampling of Starting and Packaging Materials
- Annex 13 - Miscellaneous
- General GMP
- GMP Certificates
Outcome:
Check the information provided by EMA (EMEA), because it gives you a review on cGMP-developements and offers you first-hand information from the inspectors point-of-view.