Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.
Training was cited as PIC/S’ “most important field of activity,” and following the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says considerations will be made on training inspectors on the revised Annex 1 on sterile manufacturing of the PIC/S GMP Guide, and instruments to measure the efficacy of PIC/S training events will be introduced.
PIC/S will also work toward improved co-operation with the International Coalition of Medicines Regulatory Authorities (ICMRA) and focus on the ICMRA GMP project and on the Unique Facility Identifier (UFI) as well as the PIC/S survey on the acceptance of “same scope inspection results.”
“The harmonisation of GM(D)P [good manufacturing and distribution practices] is an essential mission of PIC/S, which should consider whether to strengthen its position in areas such as Advanced Therapy Medicinal Products (ATMPs) [on which PIC/S was critical of recent changes from the European Commission], Veterinary Medicinal Products (VMPs), Investigational Medicinal Products (IMPs) or emerging technologies,” a summary of the meeting says. “Instruments to measure the use/implementation of guidance documents will be introduced and the project on a PIC/S Library providing an index of GMP guidance resources from PIC/S Participating Authorities completed.”
Current participating authorities, as well as prospective members, include:
In terms of financing, considerations will be given on possible ways to reduce staff costs and office-related costs, while considerations for third-party funding and a fee increase will be investigated, PIC/S says.
Revised GMP Guide
In terms of the revised GMP Guide, which entered into force on 1 January, all non-European participating authorities of PIC/S (and applicants) have been invited to transpose the revised chapters 1, 2, 6 and 7 into their own GMP guidelines.
Revisions to chapter 3, 5 and 8 are ongoing, PIC/S says, as well as the transposition by PIC/S of the EMA Guidelines on:
- formalized risk assessments for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use;
- the principles of good distribution practice for drug active substances;
- setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.