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.
Posted by Dr. Tim Sandle
