Hyperion Pharma Consultancy

Nederland

Vlasmeerstraat 90
5261 TC Vught

T: +31 (0) 641221798 
E: info@hyperion-consultancy.nl
W: www.hyperion-consultancy.nl

Geschreven door Wolter
PIC/S GMP Guide revised

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

Categorie:

Hyperion Pharma Consultancy uses cookies to analyze the use of the website. For example, through such statistics, it is examined how often you visit the website of Hyperion Pharma Consultancy. These cookies could also be placed by third parties. By accepting this announcement or continuing to use this site, you agree to this. More information