PCA News and Publications

August 2010
Sterile Production According To the New EU GMP Annex 1: A Focus On Capping

Regulations governing sterile manufacture of pharmaceuticals have been significantly revised since their introduction. The recent amendment to Annex 1 has seen the most controversial changes relating to the capping of vials. Pharmaceutical Inspection Cooperation Scheme has provided an interpretation of the guidelines and has published a report that offers advice on how to comply with the new recommendations. Capping is the particular focus of this article published in Pharmaceutical Technology Europe (Link)

June 2010
Detecting GMP failures

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens? Read more in this article published in Pharmaceutical Technology Europe (Link)

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