Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Food and Drugs Act are cited and discussed.
Evaluation of quality throughout process:
Raw materials and API
Process Analytical Technology
Explore new uses of analytical techniques
To perform laboratory tests or examinations:
Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions.