Revised PIC/S GMP Guide

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
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Geneva, 31 January 2014: the PIC/S Committee has adopted by written procedure the revision of the PIC/S GMP Guide (PE 009-11). The revised GMP Guide will enter into force on 1 March 2014.

The following parts have been amended:

  • Part II of GMP Guide (Q7A): Introduction of risk management principles

  • Annexes:

  • Revised Annex 2 (biological medicinal products for human use)

  • Revised Annex 14 (products derived from human blood or human plasma)

http://www.picscheme.org/news.php

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Thank you for your updations.

From
Jagan