FDA Presents its Annual Report on Drug GMP: All is Average
[Thursday, May 16, 2019]

FDA annual report on the “State of Pharmaceutical Quality” shows that most the manufacturing sites audited by FDA have an average score of between 7-8 out of 10. Two-thirds of all drugs sold in the US are manufactured in the US, India and China with the US-based sites accounting for about 40%, those in India about 13% and those in China about 12%. Not all manufacturing sites are equal; a few sites manufacture very large number of products registered with the FDA. For example, in the US, out of 1823 registered sites, three sites manufactured about 9.5% of all products listed with FDA. Similarly, in India out of 561 sites registered with the FDA, 3 sites accounted for 11.2% of all products registered from the country with the FDA. This disparity in the distribution of products manufactured at a given site indicated that FDA prioritized audits at the facilities with more activities compared to those with few products. FDA also stated that a large number of manufacturing sites registered with FDA did not even have a single product in the US market indicating over-registration by sites. For example, about half of all sites registered with FDA from South Korea did not have any products in the US market and hence did not even need to register with FDA. Sites with no products in the US were purged from FDA lists to reduce noise in the registration database. Most new manufacturing site registrations happened for packaging and labeling companies indicating that more companies were outsourcing these tasks. The number of GMP inspections conducted by FDA in a given country were proportional to the number of registered sites in that country. The US based sites were subject of about 47% of all FDA inspections while those in India accounted for 13% of all inspections and China for about 9%. Facilities manufacturing immunological agents were found to have the greatest number of manufacturing defects (about 17% of the all defects observed) while all other product categories accounted for 2-4% defects. The report provides general trends, not specifics; but it is used by FDA to demonstrate that overall the quality of drugs sold in the US is acceptable with no major causes for concerns.