PIC/S resuming onsite and desktop assessments this year

Regulatory NewsRegulatory News | 06 June 2022 |  By 

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced plans to restart assessments for countries applying for membership, though it said these audits will be subject to available resources and other priorities. Such assessments will be conducted either onsite or though desktop assessments.
These plans were shared in the PIC/S 2022 work plan, which discusses the organization’s planned activities through the end of the year or in 2023, including upcoming assessments, plans for revising or drafting new good manufacturing practice (GMP) guidelines, working group activities and training activities.
PIC/S noted that assessments and reassessments were “put on hold” in 2021 and 2022 except for virtual assessments of China’s National Medical Products Administration (NMPA), which is applying for pre-accession, and Bulgaria’s Drug Agency (BDA) and Saudi Arabia’s Food and Drug Authority (SFDA), which are applying for accession.
Pre-accession is the primary step used to apply for PIC/S membership and includes an assessment that measures gaps between the system used by the regulatory authority and PIC/S membership requirements. PIC/S authorities invite regulators to apply for membership based on the results of the gap analysis and countries apply for accession.
This year, PIC/S plans to assess, either onsite or through document review, Armenia’s Scientific Centre of Drug and Medical Technology Expertise (CDMTE), Azerbaijan’s Analytical Expertise Center (AEC), Bulgaria’s BDA, China’s NMPA, Jordan’s Food and Drug Administration (JFDA) and Saudi Arabia’s SFDA. These countries are applying for accession or pre-accession.
These countries will be reassessed: Chinese Taipei’s Food and Drug Administration (TFDA), Indonesia’s National Agency of Food and Drug Control (ADFC), New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe), and South Africa’s Health Products Regulatory Authority (SAHPRA).
PIC/S announced that “due to travel restrictions to Russia, the application by the Competent Authorities of Russia … will be frozen until further notice.”
Related to assessments, PIC/S announced its Working Group on Remote Assessments, established in October 2021, will be harmonizing the terminology on inspectors’ qualifications and best practices for remote assessments.
In addition, the Working Group on Inspection Reliance, which is collecting yearly statistics on GMP inspections based on desktop assessments, will be revising its template on yearly inspection reliance statistics to add specific questions on “existing barriers to inspection reliance.”
GMP guide revisions
There are also plans in the works to finalize Annex 1 of the GMPs for sterile products, which will be aligned with the EU’s upcoming Annex 1 revision scheduled for release in the second or third quarter this year. PIC/S is considering establishing an Expert Circle on Sterile Products to train inspectors on Annex 1. (RELATED: EU GMP Annex 1 revision to be released mid-year, Regulatory Focus 15 March 2022)
There are plans to either revise or finalize the GMP Guide Chapter 1 on pharmaceutical quality systems, as well as Chapter 4 and Annex 11 on documentation and computerized systems.
Working group activities
There are also plans to update the PIC/S Aide Memoire on Controlling Cross-Contamination on Shared Facilities (PI 043). In addition, the Working Group on Data Integrity will discuss whether to finalize its Aide Memoire on PIC/S Data Integrity System-Specific Guidance: Chromeleon 7 Chromatography Data Systems and Server/Client Systems.
A stakeholder consultation on the revised version of PI 006-3 Recommendations on Qualification and Validation is also scheduled for release this year.
In addition, two expert circles were created this year, one on Clinical Practices (GC) and the other on Good Pharmacovigilance Practices (GVP). Plans are also being made to reactivate the Expert Circle on Active Pharmaceutical Ingredients (API) and select a new chair.
In addition, an aide memoire on inspecting manufacturers and wholesale distributors for compliance with Good Distribution Practices (GDPs) and a Q&A for the PIC/S GDP guide will be finalized this year.
Training activities
PIC/S will be holding a training event in Dublin on 5-7 October to discuss pharmaceutical quality system (PQS) inspections. The group’s Expert Circle on Quality Risk Management (QRM) will hold an in-person meeting in Sao Paulo from 29 November to 1 December 2022.
PIC/S work plan


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