New PIC/S Q&A Document regarding Distribution Activities for APIs
![GDP in Switzerland (GDP 3)](files/eca/userImages/training.img/Z-GDP3-GDP-in-Switzerland-neues-Layout.jpg)
Recommendation
12 September 2024
Basel, Switzerland
Specifics in the Distribution of Medicinal Products (Course in english language!)
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.Author
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
16.07.2024Templates for Shortage Prevention and Mitigation Plans issued by EMA
16.07.2024New Measures to Report Medicine Disappearances
16.07.2024GDP Non-Compliance Report for Czech Wholesale Distributor
16.07.2024Checklist for Implementation of GDP Principles - Part 9: Transportation
12.06.2024EU adopts Supply Chain Law - Implications for pharmaceutical Companies