Pharmaceutical Quality Assurance
In the pharmaceutical industry, quality assurance (QA) in Pharma is essential for ensuring that pharmaceutical products are manufactured to a safe and consistent standard. Pharmaceutical quality assurance is a very broad field that refers to any aspect that may affect a drug's quality during its research, development, manufacturing, and sales phases.
Pharmaceutical Quality Systems (PQS) is a management system to direct and control a pharmaceutical company in terms of quality. This definition of ICH Q10 is based on the definition from the family of ISO 9000 standards, with the primary objective of ensuring the quality and efficacy of the medicinal product, and patient safety, while improving the overall level of quality and the performance of the business. The management system is based on prior establishment, throughout the life cycle of the pharmaceutical product, of a quality strategy to achieve these objectives.
Pharmaceutical Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. Pharmaceutical Quality Systems (PQS) consist of eight pillars, which are designed to provide high quality finished pharmaceutical products, with quality assurance in pharma and PQS working together in synergy.
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