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GMP Quality

GMP Quality provides information about Good Manufacturing Practices for the manufacture of Drug Products (DP), Active Pharmaceutical Ingrediences (API) and Medical Devices (MD)

This site is intended to serve all individuals working in a GxP regulated environment.

Our aim is to provide general guidance for the daily work. You will find Guidelines e.g. on Documentation or on how to build a FDA compliant Quality Manual.

Our selection of Literature will give you a good overview about the standards you should have in your office for quick reference.

Our News section is specifically providing news related to the US Food and Drug Administration, the leading Health Agency in regard to current GMPs. You will also find the FDA history and FDA overview here on GMP Quality.

A listing of the major health agencies is as well on this site.

Our Glossary listing should give you the most important Quality definitions.

If you should have material to share with colleagues around the world e.g. SOPs or Standards or any kind of templates do not hesitate to send it in for publication. If you should miss content on our web space just let us know. e-mail to: info@gmp-quality.com

GMPSOP - Standard Operating Procedure

SOP are the basis for any Quality related activity. By using the FDA and EMEA conform SOP templates from our partner web sites you can safe a lot of time and resources during the implementation of quality systems.

SOP tempaltes are availiable on:

Online Consultancy or SOP - Standard Operating Procedure

Here are more sites with information on Good Manufacturing Practice

Europe Wikipedia England Pharmweb Compliance PDA TGA ISPE Eudralex WHO Pharma NSF

GMPGood Manufacturing Practice -- Expert Network
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