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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.

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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.

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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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Contract Manufacturing Arrangements for Drugs: FDA Draft Guidance Quality Agreements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).

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Good distribution practices for active substances for medicines for human use No. 2015 / 10 Bis

These guidelines are based on Article 47 fourth paragraph of Directive 2001 / 83 / EC of the European Parliament and of Conseil1. They follow the principles on which the guidelines are also based on the volume of 4 EudraLex, Part II, Chapter 17, regarding the distribution of active substances and the guidelines of November 5 2013 on good distribution practices wholesale medicines for human use.

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Commit to share
Transmit and progress together
Promoting innovation

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.

More info on video (Versiongb here )


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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.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               Youtube   linkedin