New PIC/S Q&A Document regarding Distribution Activities for APIs

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 to

Part 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:

  • Should financial records in addition to GMP documents be examined during inspections?
  • How can the finished product manufacturer be sure about the integrity of the whole API supply chain?
  • Which kind of information is requested about transport conditions of APIs and is a transport validation needed?
  • On which aspects should inspectors focus on during inspections of brokers/traders?
  • What are repackaging and relabelling activities, particularly since PIC/S GMP Guide Part II gives no definition of them?
  • Should stability studies be conducted on repackaged APIs?

For details please see the

new Q&A document available on the PIC/S website.

Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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