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Good Manufacturing Practices 2015 / 12 bis

Decision of December 29 2015 on good manufacturing practices Official Journal of the French Republic on January 29 2016, 34 188 text.

This edition includes the latest versions of 3,5,6 and 8 chapters of Good Practices in European manufacturing.

Good Manufacturing Practices 2015

Implementation of Guidelines for Elemental Impurities Q3D Training Package

This Implementation Working Group (IWG) Was endorsed by the ICH Steering Committee in October 2014. Throughout the development of the Guideline Q3D, external audiences, constituents and interested parts-have Clearly Communicated the complexity of the implementation Approaches for this guideline.


Contract Manufacturing Arrangements for Drugs: FDA Draft Guidance Quality Agreements

This guidance Describes our current thinking there Defining, Establishing, and Documenting the Responsibilities of Each party (or all parts) Involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).


RX-360 Best Practices Guide Quality Agreement

This Best Practices Guide Quality Agreement is Intended to assist Both Customers and Suppliers Efficiently managing in the initiation, negotiation, implementation, and Ongoing Maintenance of quality agreements. Generally, entre Such agreements are drug manufacturers and Their material and the service providers (ie manufacturers of APIs, excipients, packaging materials, etc. as well as provider of GxP services, analytical or --other services to drug manufacturers.


USP Pharmacopeial: 41 (6) In-Process Revision (November-December 2015)

"This section contains Proposals for adoption as official USP or NF standards (Either Proposed Proposed new standards or revisions of current USP or NF standards). These May be'any of the Following: (1) Proposed revisions Placed Directly under In-Process Revision, gold (2) modifications of Previously Proposed revisions under In-Process Revision. Readers shoulds review material in this section and Provide comments to the Scientific Liaison using the contact details Appearing at the end of Each proposal. Information on how to comment can be found under the "Participation" section of www.usp.org. It is significant to send comments aussitôt, using the comment deadline listed after-Each title "


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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
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