GMP Guide for Healthcare establishments

Good manufacturing practice (GMP) standards are important in order to ensure that the procuring, storing and manufacturing of medicinal products is of high quality and safe for consumer use. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide has been in use as guidance for GMP standards that need to be followed by the concerned drug manufacturers or particular establishments.

Recently, the PIC/S Committee has issued the revision of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4). The guide also includes a new Annex 3 on radiopharmaceuticals. This is a revised document and will be effective from 1st March 2014.

Similarly, the PIC/S Committee has adopted the revision of the PIC/S GMP Guide (PE 009-11), which will be effective from 1st March 2014.

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