Pharmacopeial specifications and analytical data from post-marketing quality sampling and testing programs: A perspective beyond out-of-specification results

Abstract

Ensuring that marketed medicines meet acceptable standards (safety, quality, and efficacy) involves aspects of product development, compliance with good manufacturing practices, and monitoring and testing of these products already on the market. Pharmacopeias are one of the main tools used by regulatory authorities in the analytical testing for quality assessment; there are almost 60 pharmacopeias in the world. Thus, this research evaluated the potential impacts of the differences between the pharmacopeial specifications in the quality assessment of these products. It also assessed the use of analytical data to strengthen these surveillance systems. The pharmacopeial specifications for assay determination and dissolution test from United States Pharmacopeia (USP), British (BP), Brazilian (FB), Portuguese (FP), Argentine (FA), and International (Ph. Int.) Pharmacopeias were compared. The quality control reports and results of the Brazilian conformity assessment program were used to support the research. The possibility of selection of medicines or manufacturers for monitoring, sampling, and testing, as well as good manufacturing practice inspections based on analytical data were observed, even considering compliant cases or those within the tolerance limits. An important impact of acceptance criteria given in the individual monographs of different pharmacopeias regarding quality testing was also observed. Strengthening of the pharmacopeial harmonization projects and universalization of the requirements provided by the individual monographs can help in supporting the internationalization of the pharmaceutical market and improving access to medicines.