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Task of QA
ensure that the drug products have the quality required for the intended use
Quality
the nature of a drug product, which is determined by the identity, content, purity, and other chemical, physical and biological properties or by the manufacturing procedure This provides the link between the manufacture or manufacturing procedure and the quality assurance system and thus the product quality.
Definition of the document structure Release of all SOPs for the quality management system Feedback to the management board regarding the quality management system Carrying out/organisation of training courses Carrying out/organisation of self-inspections/external audits Carrying out corrective and preventive actions Inspection and release of quality-related documents (to be defined depending on the company) Management of teams (risk management, validation, qualification, deviation, change, CAPA, etc.) Archiving of quality-related documents (to be defined depending on the company) Processing of/collaboration in changes, deviations, OOS