FDA Lists the Most Common GMP Deficiencies Last Year
(Thursday, June 22, 2023)
The annual report by the Office of Pharmaceutical Quality (OPQ) lists several updates regarding FDA’s CGMP inspection program along with several interesting factoids about the status of the drug supply chain in the US. The FDA has been developing a new inspection program for the last few years and the report summarizes what it has learnt and adopted from it. The report also lists the most common audit findings during FDA inspections. There are interesting facts about the scope of products FDA regulates that may be of interest to policy wonks as well as the general public.
There are 4814 manufacturing sites registered with the FDA for the manufacture of drugs and biologics of which about 40% are involved in the manufacture of non-prescription products. Overall FDA regulates more than 140,000 products. More than 88% of these products are non-prescription products. About 2700 of these 140,000 products are considered essential medicine which are about equally split between prescription and non-prescription products (1800 and 1900, respectively). About 82% of the active pharmaceutical ingredient (API) manufacturing sites and 57% of the finished dose form (FDF) manufacturing sites for the essential medicines are located outside the US. The same trend is true for non-essential medicines as well. About 42% of the manufacturing sites registered with the FDA are located in the US, followed by about 12.5% in India, about 9% in China, and about 17% in Western Europe (distributed across 7 countries).
FDA has a scoring system for manufacturing sites for its CGMP (current Good Manufacturing Practices) inspections, called the Site Inspection Score (SIS) which ranges from 0-10, with higher scores indicating better CGMP compliance. The SIS is based on classifications of FDA’s CGMP inspections over the past ten years and is used as a proxy for compliance with CGMP requirements as defined in 21 CFR 210. Based on the SIS, the US sites and the non-US sites have very similar median compliance scores of 7.17 and 7.00, respectively.
Last year, the most common issues identified during FDA’s inspections were CGMP deviations, followed by products stored at improper temperature conditions, and release of products that failed specifications. Most of these findings led to quality-related product recalls. The most common reason for a foreign manufacturer being put on an Import Alert was because the site refused to respond to FDA’s request for documents, or because CGMP deficiencies were identified during the document review. Last year almost 4 of 5 import alerts were issued to manufacturing sites located in China or South Korea, and most of them were to hand sanitizer manufacturing sites, most likely new sites that got a pass from CGMP compliance during the Covid emergency, a waiver that expired last year.
The annual report for the OPQ is an interesting read, one that all manufacturing sites should be aware of, not only because it gives an insight into the trends but also it sets up expectations for future.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC