Posted on June 06, 2022 | By
The Pharmaceutical Inspection Co-operation Program (PIC/S) has announced its intention to restart assessments for candidate countries, although it has stated that such audits will be subject to available resources and other priorities. These assessments will be conducted either on-site or through computer-based assessments.
These plans were shared in the PIC/S 2022 work planwhich addresses the organization’s planned activities through the end of the year or into 2023, including upcoming assessments, plans to review or write new Good Manufacturing Practices (GMP) guidelines, working group activities and training activities.
PIC/S noted that assessments and reassessments have been “put on hold” in 2021 and 2022, with the exception of virtual assessments of the China National Medical Products Administration (NMPA), which is requesting pre-accession, and the Bulgarian Medicines Agency (BDA) and Saudi Arabia. Food and Drug Authority (SFDA), which apply for membership.
Pre-membership is the main step used to apply for PIC/S membership and includes an assessment that measures the gaps between the system used by the regulator and the 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 membership.
This year, PIC/S plans to evaluate, either on-site or through document review, the Armenian Scientific Center for Expertise in Medicines and Medical Technologies (CDMTE), Center of Expertise (AEC) of Azerbaijan, the Bulgarian BDA, the Chinese NMPA, the Jordanian Food and Drug Administration (JFDA) and the SFDA of Saudi Arabia. These countries are candidates for accession or pre-accession.
These countries will be reassessed: Chinese Taipei Food and Drug Administration (TFDA), Indonesian National Food and Drug Control Agency (ADFC), Medicines and Medical Devices Safety Authority (Medsafe) of New Zealand and the Health Products Regulatory Authority (SAHPRA) of South Africa. .
PIC/S announced that “due to travel restrictions to Russia, the request from the relevant authorities in Russia…will be frozen until further notice”.
Regarding assessments, PIC/S announced that its Remote Assessments Working Group, established in October 2021, will harmonize terminology on inspector qualifications and best practices for remote assessments.
In addition, the Inspection Confidence Working Group, which collects annual statistics on GMP inspections based on IT assessments, will revise its Annual Inspection Confidence Statistics model to add specific questions on “existing barriers to trust in inspection”.
GMP Guide Revisions
There are also plans to finalize GMP Annex 1 for sterile products, which will be aligned with the next EU Annex 1 revision scheduled for the second or third quarter of this year. PIC/S plans to create a circle of experts on sterile products to train inspectors on Annex 1. (RELATED: Revision of EU GMP Annex 1 to be published mid-yearRegulatory guidance March 15, 2022)
It is planned to revise or finalize chapter 1 of the GMP Guide on pharmaceutical quality systems, as well as chapter 4 and annex 11 on documentation and computerized systems.
Working group activities
It is also planned to update the PIC/S aide-mémoire on the control of cross-contamination on shared installations (PI 043). In addition, the Data Integrity Working Group will discuss whether to finalize its PIC/S Data Integrity System Specific Guidelines Cheat Sheet: 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 should also be released this year.
In addition, two circles of experts were created this year, one on Clinical Practices (GC) and the other on Good Pharmacovigilance Practices (BPV). Plans are also underway to reactivate the Circle of Experts on Active Pharmaceutical Ingredients (APIs) and select a new chair.
In addition, a checklist on monitoring compliance with Good Distribution Practices (GDP) by manufacturers and wholesaler-distributors and a Q&A for the PIC/S GDP guide will be finalized this year.
PIC/S will host a training event in Dublin from 5-7 October to discuss Pharmaceutical Quality System (PQS) inspections. The Quality Risk Management (QRM) Group Expert Circle will hold an in-person meeting in Sao Paulo from November 29 to December 1, 2022.
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