Overview of proficiency testing provision in pharmaceutical area in Brazil and an educational scheme for determining mefenamic acid in raw materials

Abstract

An historical review indicated that the provision of proficiency testing (PT) in the pharmaceutical area in Brazil is critical. Three providers were identified in the period between 2002 and 2015; only one provider was regular, but none was accredited according to the requirements of ISO 17043. A PT was organized without registration fees for educational purposes for the determination of mefenamic acid (2-[(2,3-dimethylphenyl)amino]benzoic acid) in raw materials. Proficiency test items consisted of a mixture of mefenamic acid and polyvinylpyrrolidone in the mass ratio 90:10. This proportion was used to simulate an adulterated raw material. Homogeneity and stability testing was performed and indicated that the materials were suitable for use in the PT scheme. First, 68 pharmaceutical laboratories, of which five were ISO 17025 accredited, were contacted to disseminate information about the specific PT and the benefits of this important quality assurance tool. Then, the proficiency test items were sent to the 13 registered participants, of which two were ISO 17025 accredited. In addition, the participating laboratories were surveyed regarding the technical and management aspects of their quality management system (QMS), such as the status of the accreditation process according to the ISO 17025 requirements, staff training, equipment calibration and participation in other PT schemes. All 11 participants that reported results in the study adopted the United States Pharmacopoeia Official Method. Only one laboratory, representing 9.1 % of the participants, had an unsatisfactory z-score result. Factors such as the reduced number of ISO 17025 accredited laboratories, the low number of participants in the educational PT, the high proportion of laboratories that participated for the first time and the portion of the participants who did not know about PT and its importance were considered as determinants for the restricted availability of the PT supply for medicines, as evidenced in the present study in Brazil. Thus, an urgent need for nationwide actions was identified to promote the critical consciousness of managers regarding QMS in pharmaceutical laboratories, including the importance of participation in PT schemes, as well as the importance of encouraging the providers already structured to broaden their scope in this area.