New PIC/S Guidance Documents published
The following new PIC/S Guidance documents have now been published on the PIC/S website:
- PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).
- PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
- PIC/S Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
- PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1)
The PIC/S GMP Guide (PE 009-14) has been revised according to the EU GMP Guide and are now in alignment with the principles of Quality Risk Management. Interestingly, PIC/S has already aligned Annex 17 with the yet to be released EU revision of it, mentioning that the final version will be published shortly by the European Commission.
These documents will enter into force on 1 July 2018.
In addition, the PIC/S GMP inspection guidance (developed based on an International Coalition of Medicines Regulatory Authorities framework) came into force on 1 June 2018. This guidance provides a tool and framework which aims to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines. The main feature of the guidance is that it outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection (PE 048-1).
All documents are listed on the “Publications” page of the PIC/S.