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News about GMP/cGMP


The FDA has published its yearly guidance agenda including the new and revised draft guidances CDER is planning to publish during the calendar year 2014.


Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.


Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. Additional information requested from the marketing authorisation holders in the EU and from Ranbaxy itself will also be considered.


According to the Pharmaceutical Inspection Co-operation Scheme PIC/S, the PIC/S Committee has adopted the revision of the PIC/S GMP Guide (PE 009-11). The document will enter into force on 1 March 2014.


The PIC/S Committee has adopted the revision of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4), which includes a new Annex 3 on radiopharmaceuticals.

This revised document will enter into force on 1 March 2014.


The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country. This is a significant step as at present there are no rules or guidelines to be followed by transport agencies.


Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.


As part of its transparency initiative the European Medicines Agency (EMA) has already published details of manufacturers who have violated GMP.

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