FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to strengthen the resiliency of globalized drug supply chains

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The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. Indeed, FDA was forced to accelerate its work to advance regulatory convergence with trusted foreign regulatory partners by sharing information to complete inspectional activities, to advance certain medical product applications through the review process, and to help mitigate potential drug shortages. FDA’s “Resiliency Roadmap for FDA Inspectional Oversight” issued this month, summarizes the agency’s use of alternative inspectional tools and priorities going forward, calling the work to further leverage information shared through mutual recognition agreements (MRAs) “increasingly vital.” For example, FDA assessed expanding the use of MRA beyond in-country inspections to include third-country inspections, and began to accept and classify third-country inspections.

FDA’s continued evolution of its inspectional operations by building on lessons made necessary by the pandemic was a priority of the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative, issued in January 2021, which we summarized here. According to the PREPP report, FDA’s use of MRAs with the European Union increased by about 35 percent between March 18 and October 18, 2020, compared to the same period in 2019.

As FDA and other health authorities around the globe are assessing the path forward for oversight of manufacturers and the global pharmaceutical supply chain, we expect a continued push to establish collaborative approaches that strengthen the systems of reliance. One important component of the push for greater reliance is the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S 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. PIC/S presently comprises 54 international competent authorities coming from all over the world, including the United States, Europe, Africa, South America, Asia, and Australia. The PIC/S quality system requirements must be implemented by each authority before becoming a member, which is aimed at creating agency harmonization and quality system improvements.

The PIC/S guide provides a practical “how to” baseline guide for international regulators to use that discusses essential aspects that should be considered when evaluating: Pharmaceutical Quality Systems, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced Activities, Complaints and Product Recall, and Self Inspection.

In this regard, on May 1, 2021, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) made effective its Guide to Good Manufacturing Practice for Medicinal Products Part I PE 009-15 (Part I) (PIC/S guide) describing the elements that manufacturers of medicinal products must meet to ensure that they are fit for their intended use. This work builds on PIC/S 2018 guidance on GMP inspection reliance aimed to help members prioritize resources for GMP inspections including the use of remote assessments that can be confirmed by oversight activities completed by another member.

On that same day, May 1, PIC/S also made effective another guide titled “Guide to Good Manufacturing Practice for Medicinal Product Annexes PE 009-15 (Annexes),” describing practical approaches to comply with the EU GMP Annexes 1-20. This guide provides useful information related to the changes proposed in the Annex 1 2020 revision, and covers topics related to: clean room and clean air device classification, environmental monitoring, isolator technology, blow/fill seal technology, terminally sterilized products, aseptic preparation, personnel, premises, equipment, sanitization, processing, finishing of sterile products, quality control and sterilization.

Next steps

As GMP inspection challenges continue, we expect international competent authority regulators to continue using these PIC/S guides to conduct on-site inspections and evaluate the compliance status of facilities. This may also facilitate increased mutual reliance going forward.

These PIC/S guides are not used to define a competent authority regulatory policy, but provide a good baseline for determining regulatory expectations and compliance. In particular, the Annexes document may be helpful for industry to evaluate the concepts discussed in the document to determine whether a site is compliant with current regulatory expectations.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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