Thursday, 9 August 2018

Revised PIC/S guidances

Revision of PIC/S GMP guide has been announced:  Chapters 3, 5 and 8 of the PIC/S GMP guide have been revised and will enter into force on 1 July 2018; along with adoption of transposition for PIC/S purposes of EU guidances on GMP excipient risk assessment, exposure limits and GDP for API.

The details are: 
  • Chapter 3 on “Premises and Equipment”;
  • Chapter 5 on “Production”;
  • Chapter 8 on “Complaints and Product Recall”. 
The revised Chapters 3, 5 & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by revised Chapter 5. Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised.

See: PIC/S

Posted by Dr. Tim Sandle

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