Controlo da qualidade na indústria farmacêutica e biofarmacêutica

Abstract

Quality Control (QC) in the pharmaceutical and biopharmaceutical industry is essential to ensure the safety, efficacy, and quality of medicinal products and is highly regulated in the European Union by Good Manufacturing Practices. Conducting qualitative and quantitative analyses of substances found in medicinal products is a fundamental component of QC, ensuring compliance with specified quality standards. This report presents the work carried out at Paralab during the internship that provided the opportunity to engage in QC related activities in the pharmaceutical industry. The development, validation, and transfer of an analytical method for quantifying ethanol in a pharmaceutical product were undertaken, utilizing Gas Chromatography (GC) with headspace sampling technique. Additionally, the qualification of the GC equipment and the update of a verification and calibration plan for the company's Measurement and Monitoring Equipment were performed. The internship experience offered a comprehensive practical and theoretical understanding of QC in the pharmaceutical and biopharmaceutical industry, encompassing adherence to Good Manufacturing Practices guidelines and the practical application of analytical techniques in the development and validation of an analytical method, reinforcing the significance of these stages in ensuring the quality of pharmaceutical products.

Date of Award	9 Oct 2023
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	José António Morais Catita (Supervisor)