News about GMP/cGMP


PIC/S: What’s planned in terms of GMP?

PIC/S: What’s planned in terms of GMP?

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has published its 2022 work plan with the organization’s planned actions for this year. Not only does PIC/S plan to resume its assessments for membership application but also to revise or draft new GMP guidelines.

Revision plans for GMP guidelines in close alignment with the EU include:

  • The finalisation of Annex 1 for sterile manufacturing in alignment with the new EU Annex 1, which is scheduled to be released around September this year. PIC/S is planning to establish an Expert Circle on Sterile Products to train inspectors on the new requirements coming along with the new Annex 1.
  • The revision of the GMP Guide Chapter 1 on Pharmaceutical Quality Systems is planned to be continued/finalized in close co-operation with the EMA’s Inspectors Working Goup (IWG) on GMDP. This is also anticipated for Chapter 4 on Documentation), Annex 11 on Computerised Systems and Annexes 4 and 5 on Veterinary Medicinal Products (VMPs and Immunological VMPs.
  • The publication of concept paper on veterinary specific GMP guidelines in the PIC/S Working group on VMPs.
  • The monitoring of the EU Annex 21 (importation of medicinal products) through the participation of Swissmedic in the Drafting Group. Once finalised, the Committee will need to decide whether to adapt this Annex for PIC/S purposes.

PIC/S GMDP-related guidance documents to be further revised or developed:

  • PE 010-4 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in
  • Healthcare Establishments
  • PI 006-3 Revision of PIC/S Recommendations on Validation Master Plan; Installation
  • and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation
  • PI 007 Recommendation on Validation of Aseptic Processes
  • PI 011 PIC/S Guidance on Good Practices for Computerised Systems in Regulated GxP Environments
  • PI 013 PIC/S Inspection Report
  • PI 023-2 Aide Mémoire on Inspection of Quality Control Laboratories
  • PI 025 Aide Mémoire on Medicinal Gases
  • PI 030-1 Aide Mémoire on the Inspection of APIs
  • PI 043-2 PIC/S Aide Mémoire on Controlling Cross-Contamination in Shared Facilities
  • PI 050 Aide Mémoire on PIC/S Data Integrity System-Specific Guidance: Chromeleon 7 Chromatography Data Systems and Server/Client Systems
  • PI 019 PIC/S Site Master File for Source Plasma Establishments
  • PI 020 PIC/S Site Master File for Plasma Warehouses

For GDP:

An Aide Mémoire on Inspection of Manufacturers and Wholesale Distributors for Compliance with GDP along with a Q&A for the PIC/S GDP Guide will be finalised by 2022.

Membership assessment:
With assessments and reassessments for membership put on hold for the last two years, these countries will be reassessed, which is the final step for membership: Chinese Taipei’s Food and Drug Administration (TFDA), Indonesia’s National Agency of Food and Drug Control (ADFC), New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe), and South Africa’s Health Products Regulatory Authority (SAHPRA).

The PIC/S Committee plans to meet face-to-face in Dublin, Ireland,  on 3 October 2022 in connection with PIC/S’ 50th Anniversary, which will be hosted by the Irish regulatory authority HPRA.


PIC/S: Work Plan 2022