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ECA / QGP Working Group FINALIZED GDP Interpretation Guide

The last three chapters of an interpretation of the EU Good Distribution Practice Manual (PEM) Jointly-have-been published by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (QGP). Both organizations joined Forces to Develop a Guide Intended to help colleagues in industry with the implementation of the EU GDP Guideline.

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Data Integrity and Compliance With CGMP Guidance for Industry

The purpose of this guidance is to Clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 210 CFR parts, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; 211 hand covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance Provides the Agency's current thinking on the establishment and handling of data in according with CGMP requirements.

Data Integrity and Compliance With CGMP Guidance for Industry - Draft Guidance

 

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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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

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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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 - drapeauitalie )


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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 channel   linkedin