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PIC/S GMP Guidance PE 009-13 has been revised and got into force from 1st January 2017.

PE 009-13 is the PIC/S GMP Guidance which has been revised and got into force from 1st January. The revision has been successfully completed on the Harmonisation of GM(D)P by the PIC/S Sub-Committee. The Chapters of guidance which have been undergone revision are Chapter 1, 2, 6 and 7. Chapter 1 and chapter 7 were renamed to reflect the changes. Chapter 1 on “Quality Management” has become “Pharmaceutical Quality Systems”, Chapter 2 on “Personnel”, Chapter 6 on “Quality Control”, Chapter 7 on “Contract Manufacture and Analysis” has become “Outsources Activities”.

EU and ICH guidance are taken as base for the changes in revision. The Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are revised based on the equivalent Chapters of the EU GMP Guide. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. In Chapter 6, a new section on “Technical transfer of testing methods” has been added. In Chapter 2, a section on consultants has been added.

All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide.


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