Quality Assurance
The systematic activities and procedures designed to ensure pharmaceutical products consistently meet quality requirements throughout the entire manufacturing process. QA encompasses process design, validation, documentation, training, and auditing — it is broader than quality control, which focuses on testing.
Technical Context
QA encompasses the entire quality management system (QMS) per ICH Q10: pharmaceutical quality system elements include: management commitment (quality policy, resource allocation), process performance and product quality monitoring (statistical process control, trending), corrective and preventive action (CAPA — investigating root causes of deviations and implementing systemic improvements), change management (controlling changes to processes, equipment, and materials through formal review and approval), and management review (periodic assessment of QMS effectiveness). QA activities specific to peptide manufacturing include: supplier qualification (ensuring amino acid and excipient suppliers meet quality standards), facility qualification (cleanroom environmental monitoring — viable and non-viable particle counts, temperature, humidity), equipment qualification (IQ/OQ/PQ for synthesisers, HPLC systems, lyophilisers), and annual product reviews (comprehensive assessment of all batches produced in a year, identifying trends).