PIC/S Considers New System For Monitoring Compliance By Members
Executive Summary
As more and more regulatory authorities line up to join the informal co-operative scheme for pharmaceutical inspectorates, PIC/S, there are plans to discuss the possible introduction of an annual reporting scheme to check ongoing compliance by existing members.
The international Pharmaceutical Inspection and Co-operation Scheme (PIC/S) has announced plans for a new annual reporting system to monitor whether its existing members are continuously complying with the requirements of the scheme.
In its 2019 workplan, the PIC/S states that its Sub-Committee on Compliance will discuss the "possible introduction" of an annual reporting system to check continued compliance of existing participating authorities with PIC/S requirements.
A total of 52 competent authorities currently participate in the PIC/S scheme, which is a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use.
Every year, more competent authorities apply for membership to the scheme and they are allowed to participate only if they have a comparable inspection system. Having a comparable GMP inspection scheme is one of the essential requirements for accession to the scheme.
The PIC/S also has a Joint Reassessment Programme in place since 2000 under which all existing PIC/S participating authorities are reassessed for equivalence with the PIC/S scheme on a regular basis.
In 2019, for example, five participating authorities are to be reassessed under the JRP – Argentina's Instituto Nacional de Medicamentos (INAME), Canada's Regulatory Operations and Regions Branch, the South African Health Products Regulatory Authority, Switzerland's Swissmedic and the State Service of Ukraine on Medicines and Drugs Control.
Also in 2019, PIC/S plans to evaluate accession and pre-accession applications from eight competent authorities – Armenia's Scientific Center of Drug/Medical Technology Expertise, Brazil's National Health Surveillance Agency (ANVISA), the Bulgarian Drug Agency, Italy's Directorate General for Animal Health and Veterinary Medicinal Products (DGSAF), the Jordan Food and Drug Administration, Pakistan's Drug Regulatory Authority of Pakistan, the Russian Federation/Minpromtorg State Institute of Drugs and Good Practices (FSI SID&GP) and the Saudi Food and Drug Authority.
In addition, this year, the PIC/S intends to work on "establishing a basis" for co-operating with the Association of Southeast Asian Nations' Pharmaceutical Product Working Group. Also, PIC/S plans to establish and maintain close contact with non-member competent authorities that have "signaled an interest to join PIC/S," in particular those from China and India.
Moreover, subject to the PIC/S committee's agreement, there are plans to revise the PIC scheme (PIC/S’ constitution) in 2019 to clarify the definition of members as well as the legal status of the PIC/S. The review process will be undertaken by the PIC/S Sub-Committee on Strategic Development and is expected to be completed by Q4.
In addition, the SCSD will work on implementing the recently adopted PIC/S guidance on GMP Inspection Reliance (PI 048-1) and monitor its voluntary implementation, as requested by the International Coalition of Medicines Regulatory Authorities, by collecting statistics on the application of the guidance through its three working groups on unique facility identifiers, inspector travel safety and whistle-blowers/confidential informants. (Also see "New PIC/S Guide Offers Framework For Voluntary Reliance On Foreign GMP Inspections" - Pink Sheet, 18 May, 2018.)
Also in 2019, the PIC/S data integrity working group will review the comments it received from the public on its draft guidance on "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)," which was issued for consultation last year. (Also see "PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications" - Pink Sheet, 1 Nov, 2018.) Additional guidance documents for inspectors on data integrity will also be finalized.
Moreover, there are plans to finalize this year an aide-memoire on inspection of manufacturers and wholesale distributors for compliance with good distribution practice (GDP) and a Q&A document relating to the PIC/S GDP Guide.
Other elements in PIC/S 2019 workplan include further revising the:
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- PIC/S GMP guide in close co-operation with the European Medicines Agency's inspectors working party on good manufacturing practice and good distribution practice (GMDP);
- PIC/S GMP Guide for Blood Establishments (PE 005-3) and the PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PE 008-3)
- PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (to add annex on guidance on total parenteral nutrition;
- Revision of PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation;
- PIC/S Guidance on Good Practices for Computerised Systems in Regulated GxP Environments;
- Aide Memoire on Inspection of Quality Control Laboratories; and
- Aide-Memoire on the Inspection of active pharmaceutical ingredients.
The PIC/S says it will also continue to provide training to GMDP inspectors and organize discussions on various related topics.
From the editors of Scrip Regulatory Affairs.