WHO Consults On Standardized Approach To Verifying Good Practices At Foreign Sites
Executive Summary
The World Health Organization has prepared a draft list of documents and certificates that national regulatory authorities can rely on to verify compliance with the most relevant good practices in relation to medicinal products that underwent manufacturing and clinical trials at foreign sites. The proposed approach can reduce duplicate, and the frequency of, inspections.
The World Health Organization is inviting stakeholder feedback on a standardized procedure that national regulatory authorities (NRAs) can follow to carry out a desktop review of inspection reports issued by trusted, competent regulatory bodies in order to verify compliance with good practices concerning manufacturing, quality control and conduct of clinical trials of medicinal products in foreign countries.
The WHO’s proposed “desk assessment pathway” is outlined in a draft guideline which, when finalized, could result in foreign drug manufacturers and clinical trial sites facing fewer inspections because NRAs would be able to rely on “authentic and reliable documentary evidence from other regulatory authorities,” the WHO said.
Specifically, the guideline applies to manufacturers of finished pharmaceutical products and active pharmaceutical ingredients, clinical trial sites and clinical research organizations, and quality control laboratories subjected to good practice (GxP) inspections in foreign countries. The procedure can also be used by NRAs for the assessment of national sites and to define their own inspection programs.
The guideline outlines a set of essential information and documents that drug manufacturers, quality control laboratories and clinical trial sponsors should make available to NRAs to enable them to undertake desk assessment in relation to the most relevant GxPs, namely manufacturing (GMP), quality control (GLP) and clinical trials (GCP). It clarifies, however, that the desk assessment process does not preclude an on-site inspection in cases where the outcome of the assessment shows non-compliance with stipulated practices.
While the desk assessment process to verify compliance with GMP and GCP has been used by the WHO’s Prequalification Team, the European Medicines Agency and Australia’s Therapeutic Goods Administration for some years, the WHO notes that “for others it is an emerging consideration.” The organization explains that it decided to develop formal guidance on this front following a request from national medicines regulatory authorities who attended a training symposium on collaborative registration procedures in Kenya in September 2016.
While the WHO’s guideline has general geographical applicability, it is more relevant to regulatory authorities in low- and middle-income countries where it can help support ongoing harmonization initiatives and help make optimum use of limited resources. The guideline clarifies that desk assessment procedures cannot be applied to sites that have failed GxP inspections, and that the NRA is ultimately responsible for deciding whether it is appropriate to perform a desk review.
The desk assessment process depends on several factors, such as whether the facility was previously inspected by one of the competent NRAs, or a member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) or under the WHO’s prequalification scheme, and whether any agreements are in place between the NRA and the foreign country, such as for mutual recognition, cooperation or memoranda of understanding.
The guideline lists specific documents and certificates for each type of facility –manufacturer of sterile or non-sterile FPPs, APIs and biotech; outsourced testing laboratory; and CROs – that must be submitted as evidence to enable desk review of applications in the following cases:
- Where a mutual recognition agreement exists.
- Where a cooperation agreement or an MoU exists or the facility has been inspected by a PIC/S member or a stringent regulatory authority, or under the WHO prequalification scheme
- Where no agreements are in place and the facility has not been inspected by a trusted regulator.
It also has annexes on model report formats for desk assessment of FPPs and API manufacturers, quality control laboratories, and CROs/clinical trial sites.
Comments on the draft guideline will be accepted until July 15.
From the editors of Scrip Regulatory Affairs.