News about GMP/cGMP

24.01.2017

PIC/S GMP Guide revised

The following chapters of the PIC/S GMP Guide have been revised based on the equivalent chapters of the EU GMP Guide:

  • Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”)
  • Chapter 2 on “Personnel”
  • Chapter 6 on “Quality Control”
  • Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsourced Activities”).

 

 

However, according to PIC/S there are some minor differences in terms of language. Chapters 1, 2 and 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated.

The revised GMP Guide (PE 009-13) entered into force on 1st January 2017.


Source:

PIC/S: News



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