GMP NEWS 2007

New GMP-Guide on Qualification Approved by the ASTM

The GMP News from 17 May 2006 already reported about the draft of the Guide on Qualification by the American Society for Testing and Materials (ASTM). It is entitled "Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (E2500-07)".

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The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All

After the Office of New Drug Quality Assessment (ONDQA) within the Center for Drug Evaluation and Research (CDER) of FDA had published a very interesting document as early as February 2007, but had withdrawn it soon afterwards (MAPP - Manual of Policies and Procedures 5310.7; see our GMP News of 9 May 2007), the document now came into force again on 3 November 2007!

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Swiss Biotech Association and IFAPP in co-operation with the ECA

Companies across Europe have been realising the importance of a close interaction between GMP and GCP in the organisation and initiation of sound and appropriate clinical trials. A key element for a successful development of a pharmaceutical product is the thorough planning of the clinical trial supplies.

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Validation Aspects in US FDA Warning Letters

In the GMP News of 10 January 2007, the FDA Warning Letters Report with a "top five" list of pharma-relevant warning letters issued in Fiscal Year 2006 was presented.

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