PIC/S adopts technical interpretation of revised GMP requirements for sterile products

The committee of the international Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted a long-awaited technical interpretation of the revised good manufacturing practice requirements for sterile medicinal products, which came into effect earlier this year1,2.

The committee of the international Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted a long-awaited technical interpretation of the revised good manufacturing practice requirements for sterile medicinal products, which came into effect earlier this year1,2.

The requirements are listed in the revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile medicinal products, which came into effect on 1 March 2009; the...

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