What are the major steps CHPA member companies take to assure drug components from their suppliers are of high quality?
CHPA member companies first determine the required material specifications for the items that go into making a product, and then perform due diligence to identify and qualify suitable suppliers. This process can include steps such as completion and review of supplier questionnaires; review of external audit reports; testing of critical product parameters; site audits; review of registration information as required; and scale up, stability, and validation as appropriate. In many cases, a company will choose a supplier where there is an existing relationship; building a trustworthy supplier relationship is regarded as one of the most important aspects of supplier quality assurance. Once a company begins receiving drug components from a supplier, it has and follows written procedures for receipt, handling, sampling, and testing of components. No lot of components can be used until the manufacturer’s quality control unit has sampled, tested, or examined it, and then released it for use.
