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:
- The formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
- The principles of good distribution practice for active substances of medicinal products for human use
- 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