PIC/S publishes Annual Report for 2022

PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonised standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?

The following is a look at the report from an industry perspective. At 46 pages, the report is quite lengthy and includes two annexes. Annex I describes the PIC's path to becoming PIC/S. Right at the beginning, it is mentioned that the PIC/S now has 54 members. These members are listed in Annex II. Armenia, Bulgaria, Jordan and Saudi Arabia are currently applying for membership. The Russian Federation's application for membership is currently on hold.

The PIC/S attaches great importance to training and had conducted virtual and face-to-face training courses for inspectors in 2022. The PIC/S has newly launched the PIC/S Inspectors' Academy (PIA). The academy is intended to provide harmonized and standardized GMP online training. The aim is to provide consistent training for GMP inspectors. 

The PIC/S now has seven sub-committees, with the Expert Circles and the Compliance Committee being of particular interest.

The Compliance Committee includes Working Groups that deal with the following GMP aspects:

• Working Group on Annex 1 
• Working Group on the Revision of Annex 2 
• Working Group on Data Integrity
• Working Group on Harmonisation of the Classification of Deficiencies 
• Working Group on Controlling Cross-Contamination in Shared Facilities
• Working Group on the Revision of PIC/S Guidance Documents for Blood
• Working Group on the revision of PI 006
• Working Group on the Aide Memoire on Tissues and Cellular Therapy Products Inspections

One of the main tasks of the Compliance Committee is also the revision of PIC/S and EU GMP Guidelines and Annexes. Work is being done on the following documents:

• Chapter 1 (Pharmaceutical Quality System) of PIC/S-EU GMP Guide  
• Chapter 4 (Documentation) and Annex 11 (Computerised Systems) of PIC/S-EU GMP Guide 
• Annex 4 & 5 (Veterinary Medicinal Products)
• Annex 13 (Investigational Medicinal Products) of PIC/S-EU GMP Guide   
• Annex 16 (Certification by an Authorised Person & Batch Release) of PIC/S-EU GMP Guide 
• Annex 21 (GMP Obligations for Importation to the EU) of EU GMP Guide
• PIC/S Inspection Report Format

Revisions of the following PIC/S documents are also planned: PI 11-3 (Computerised Systems), PI 023-2 (Inspections of QC Laboratories), PI 030-1 (Inspection of Active Pharmaceutical Ingredients), PI 010-4 (Manufacturing of Pharmaceuticals in Healthcare Facilities).

Joint inspections will be planned again in the near future, as well as training for new inspectors.

The Expert Circles of the PIC/S have the aim to prepare draft guidelines and to provide training in specific areas. The following expert and working groups exist:

• Expert Circle on API
• Expert Circle on Cross Contamination Control in Shared Facilities
• Expert Circle on GDP
• Expert Circle on Human Blood, Tissues, Cells & ATMPS
• Expert Circle on QRM 
• Working Group on GCP/GVP
• Working Group on Medicinal Products for Veterinary Use 
• Working Group on Computerised Systems

Another interesting sub-working group is on the topic of strategic development and cooperation. One of the working groups of this sub-working group deals with the topic "Unique Facility Identifiers (UFI)". There are different systems to identify location of a drug manufacturing site. The goal of the working group is to harmonize these systems. An original proposal was to use the WGS84 system (geocoordinates) in a specific format, along with the site name and address and the national "identifier." But this proposal was revised to include "geocode precision fields". There are plans to conduct a survey to learn whether geocodes may be transferred to inspectorate databases. The revisions will also involve a change in the PIC/S inspection format, and the Site Master File is expected to change. Through the Site Master File, companies are to provide geocodes that will then be verified by inspectors in the field.

The "innate" PIC/S topic of trust in inspection, with the goal of mutual recognition, is discussed heterogeneously within PIC/S. Despite various measures, a survey showed that some participating regulatory authorities do not trust the PIC/S inspection reports of other participating authorities. A working group is now to identify the obstacles (survey).

A working group on Remote Assessments is currently developing a guideline on "remote assessments" and on "hybrid assessments". The working group is also working on an aide memoire on these two topics.

The report closes with information on collaborations with other organizations and financial issues (e.g. budget).

Conclusion: The abundance of sub-groups and resulting additional working groups make PIC/S very active. Although inspections of PIC/S member states are partially recognized, there is still room for improvement in this respect. 

The report can be viewed on the PIC/S website.