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News about GMP/cGMP


The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.


The EMA has published a "Questions & Answers Document on the EU framework for (traditional) herbal medicinal products, including those from a non-European tradition".


As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. Together with drug manufacturers, wholesaler distributors, repackers and many dispensers the FDA is working on the development of standards for this new system.


The EMA has published the “Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.


With the beginning of this month, the FDA has published the following two updated lists of guidance documents:


This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. A presentation to the WHO Expert Committee is planned for October 2014.


The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.

The revised document will enter into force on 1 October 2014 and then supersede the previous version of 2005.


On 1 April 2014, the European Commission has published a “Question and Answer” document (version 1.0, March 2014) responding to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.

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