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GMP Guidelines

How to find GMP Guidelines

 

The GMP Guideline Database contains more than 1,200 GMP Guidelines e.g. from EU/EMA, FDA, ICH, PIC/S, WHO as well as industry interpretation from PDA, ISPE, IPEC, APIC and many more. You can easily access the GMP Guidelines via the link provided in the database. If the guideline is not available for free on the web (e.g. interest group documents, ISO standards etc), you will find a link to the page where you can order the guide.

 

How it works

 

Just enter your request in the "Keyword" field above and click on "Start".

Tip:
If the result of your search is not successful, please try again with more general terms. For example, search for "validation" instead of "Process Validation"

Direct Links to important GMP topics

Please find below some direct links which will guide you to a list of GMP Guidelines:

Validation Guidelines API Guidelines 
Sterile and Aseptic Processing Guidelines  Excipient Guidelines 
Computer Validation Guidelines  Medical Device Guidelines 
Inspection and Auditing Guidelines  Blood Product Guidelines
Quality Control Guidelines  Biologic Guidelines 

1,200 GMP Guidelines on a CD

 

The European Compliance Academy has developed a software tool which contains more than 1,200 GMP Guidelines from all major authorities such as the US FDA, the EU/EMA, the PIC/S, ICH, and many more. The GMP Guideline Manager is available at no cost for all ECA Members. In addition to the CD-ROM, we also offer an online version and a smartphone GMP App exclusive for ECA Members. Learn more here about how to become ECA Member.

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