Rammell Consulting Limited

Certification by a qualified person and batch release – Consultation

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A concept paper on revising Annex 16 of the guide to good manufacturing practice: certification by a QP and batch release is currently open for consultation until 31/01/2012 using the following link to the EMA website: http://bit.ly/yTocBW

The concept paper succinctly describes some of the challenges in certifying batches of manufactured drug product for release in an environment where different parts of the manufacturing process are often conducted in different places around the globe and frequently by different companies. This also presents a challenge from a document management perspective; it is not always clear who has responsibility for maintenance of the constituent parts of the product specification file and which records, if any, the QP is expected to maintain, be responsible for or simply to just have access to. It could be argued that this clarification best sits in Chapter 4 of Volume 4 GMP Guidelines but perhaps the scope of the revision to Annex 16 should also cover documentation?

Any comments on the concept paper should be submitted to the EMA by end-January.

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