Measurement uncertainty associated with the microbial counts of pharmaceutical products

• Grant number: 19/15549-4
• Support Opportunities: Scholarships in Brazil - Master
• Start date: June 01, 2020
• End date: June 30, 2021
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Felipe Rebello Lourenço
• Grantee: Francielle Regina Silva Dias
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Microbial contamination can lead to loss of safety and efficacy of non-sterile medications. Despite the measures to ensure the reliability of microbiological results, such as the verification of the suitability of analytical methods, proficiency tests and accreditation according to ISO 17025, there is some degree of uncertainty associated with analytical measurements. The procedures for assessing the measurement uncertainty associated with chemical and physicochemical assays of pharmaceutical products are described in the literature, however there is little information available on the assessment of uncertainty in microbiological assays, particularly with regard to the count of microorganisms in non-sterile pharmaceutical dosage forms. The present work has as general objective to evaluate the measurement uncertainty associated with microbial count of non-sterile pharmaceuticals using botton-up and top-down approaches, as well as estimating the risks of false decisions regarding conformity (or non - conformity) due to uncertainty. For this purpose, five microorganisms are used: Aspergillus brasiliensis (ATCC 16404), Candida albicans (ATCC 10231), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 8027), Staphylococus aureus (ATCC 6538). We hope we'll be able to identify the most relevant sources of uncertainty for microbial count and to propose strategies to reduce the final uncertainty. In addition, we hope to contribute to reducing the risk of failure decisions based on the uncertainty assessment, the establishment of guard-bands, as well as the definition of procedures for retesting in case of doubtful results. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

SEPAROVIC, LUCIANA; SIMABUKURO, RENAN S.; COUTO, ALDO R.; BERTANHA, MARIA LUIZA G.; DIAS, FRANCIELLE R. S.; SANO, ADRIANO Y.; CAFFARO, ARTHUR M.; LOURENCO, FELIPE R.. Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses - A Review. CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY, JUN 2021. (18/25734-0, 19/15549-4, 19/16206-3)

SEPAROVIC, LUCIANA; SIMABUKURO, RENAN S.; COUTO, ALDO R.; BERTANHA, MARIA LUIZA G.; DIAS, FRANCIELLE R. S.; SANO, ADRIANO Y.; CAFFARO, ARTHUR M.; LOURENCO, FELIPE R.. Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses - A Review. CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY, v. 53, n. 1, p. 16-pg., 2021-06-08. (19/16206-3, 18/25734-0, 19/15549-4)

Academic Publications

(References retrieved automatically from State of São Paulo Research Institutions)

DIAS, Francielle Regina Silva. Measurement uncertainty associated with microbial count of pharmaceutical products. 2021. Master's Dissertation - Universidade de São Paulo (USP). Conjunto das Químicas (IQ e FCF) (CQ/DBDCQ) São Paulo.