28/29 September 2021
The range of documents (Aide Memoires and Guidance Documents) available for PIC/S inspectors has been extended to the category of Questions & Answers documents.
The first Q&A document published is intended to support inspectors during API inspections regarding distribution activities and repackaging.
Some answers refer toPart II of the PIC/S Guide. It seems to be useful against the background of the revised Pharma Directive 2001/83/EC through which inspections in the logistics chain will become more and more important.
Here are some of the topics dealt with in the 13 questions and answers:
For details please see thenew Q&A document available on the PIC/S website.
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)