New PIC/S Guidance Documents

The following new PIC/S Guidance documents have been adopted:

PIC/S Aide-Memoire on “CrossContamination in Shared Facilities” (PI 043- 1).

The purpose of this Aide-Memoire is to assist GMP inspectors in the assessment of the risks to the product from cross-contamination in shared facilities. This document provides guidance for GMP inspectors to use in preparation for, and performance of, inspections. It promotes a risk-based approach.

PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate GMP 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 GDP for active substances for medicinal products for human use (PI 047-1).

Also, the following Chapters and Annex of the PIC/S GMP Guide have been revised:

• Chapter 3 on “Premises and Equipment”;
• Chapter 5 on “Production”;
• Chapter 8 on “Complaints and Product Recall”;
• Annex 17 on “Real Time Release Testing and Parametric Release”.
• The revised Chapters are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language.

See PIC/S: https://www.picscheme.org/en/news?itemid=51

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology