News about GMP/cGMP


PIC/S Work Plan 2019

At the beginning of the year, PIC/S published its annual work plan for 2019. In addition to organisational matters, a new group of experts on veterinary medicines will be set up and the training of inspectors will be further expanded. In the area of harmonisation, PIC/S is actively involved in the revision of the EU GMP guidelines.

The following documents of the EU GMP Guide are currently revised in close cooperation with the PIC/S:

  • Chapter 1 Pharmaceutical Quality System
  • Chapter 4 und Annex 11 Documentation & Computerised Systems
  • Annex 1Sterile Medicinal Products (with WHO)
  • Annex 2 Biological Medicinal Substances & Products for Human Use
  • Annex 21 Import of Medicinal Products.

These documents are planned to be revised by the PIC/S by the end of this year:

  • PE 005-3 & PE 008-3 PIC/S GMP Guide for Blood Establishments (PE 005-3) and PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PE 008-3)
  • PE 010-4 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (to add annex on guidance on Total Parenteral Nutrition (TPN))
  • PI 006-3 PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation
  • PI 011 PIC/S Guidance on Good Practices for Computerised Systems in Regulated GxP Environments
  • PI 023-2 Aide Memoire on Inspection of Quality Control Laboratories
  • PI 030-1 Aide-Memoire on the Inspection of APIs.

In addition,

  • the PIC/S Guidance on Classification of Deficiencies (PI 040-1) entered into force on 1 January 2019, and
  • the Working Group on Data Integrity will review the comments received following the focused public consultation on the draft “PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” (PI 041-1 (Draft 3)


PIC/S Work Plan 2019PIC/S Work Plan 2019