News about GMP/cGMP


PIC/S: New Strategic Plan for 2017-2019

During its February Meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) unveiled a new road map for the next two years.


PIC/S declared training to its most important field of activity. Considerations will be made on training inspectors on the revised Annex 1 on Sterile Manufacturing of the PIC/S GMP Guide corresponding to the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says.

In addition, PIC/S plans to improve co-operation with the International Coalition of Medicines Regulatory Authorities (ICMRA) which is a strategically important organization.

The harmonisation of GM(D)P is another essential mission of the PIC/S. It is considered whether to strengthen the position in areas such as:

  • Advanced Therapy Medicinal Products (ATMPs) – for which changes the European commission recently has been criticized by the PIC/S
  • Veterinary Medicinal Products /VMPs)
  • Investigational Medicinal Products (IMPs).

Here is a summary of the latest PIC/S developments in GM(D)P Harmonisation:

  • The newly revised GMP-Guide (PE 009-13) entered into force on 1 January 2017. This includes the revised Chapters 1, 2, 6 and 7 of the EU GMP Guide.
  • A revision of Chapters 3, 5 and 8 of the PIC/S GMP Guide is ongoing as well as the transposition by PIC/S of the EMA Guidelines on:
  1. The formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
  2. The principles of good distribution practice for active substances of medicinal products for human use
  3. Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.
  • A PIC/S Working Group will be established for the revision of the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3).
  • For the draft revision of Annex 1 (Sterile Manufacturing) to the PIC/S and EU GMP Guide, a joint public consultation with the EMA will be launched. The WHO is agreed to be involved as well.
  • The Committee was informed of a proposal by the Sub-Committee on GM(D)P Harmonisation (SCH) to develop in the future some minimum requirements in PIC/S equivalent to Annex 16 to the EU GMP Guide (Certification by a Qualified Person (QP) and batch release).
  • The 6-month trial implementation period for the draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) ended on 28 February 2017.
  • The PIC/S Working Group on Controlling Cross-Contamination in Shared Facilities (CCCISF), has finalised a draft PIC/S Aide-Memoire on Cross Contamination in Shared Facilities that is currently under internal consultation.
  • The Committee was updated on the status of development of the draft PIC/S guidance on Classification of Deficiencies by the PIC/S Working Group.
  • The PIC/S Expert Circle on GDP, has finalised a draft Aide-Memoire on Inspection of Manufacturers and Wholesale Distributors for Compliance with GDP and draft Q&A for the PIC/S GDP Guide. An internal consultation will be launched shortly.

There are 5 more applicants for membership:

  • Brazil / ANVISA
  • Iran / IFDA
  • Italy (Vet) / DGSAF
  • Mexico / COFEPRIS
  • Turkey / TMMDA


PIC/S Press Release