News about GMP/cGMP

• 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