Quality Assurance

Quality Assurance - Safety First!

Quality Assurance is about safeguarding the patient's well-being, by assuring that all operations associated with the manufacture of a medicinal product are of a standard that assures the patient's expectations of safety and efficacy are met.

Quality Assurance is both a state of mind, and an understanding of the regulations and guidances relating to the development and manufacture of medicinal products for both human and veterinary medicines.

Quality Assurance - Details, Details!

In practice, Quality Assurance is about details; checking that the i's are dotted and the t's crossed; that what has been declared to have happened, did in fact happen, and happened in the manner detailed in the record. Quality Assurance applies for both drug substances (APIs) and medicinal products, and includes current Good Manufacturing Practices (cGMPs), as well as any necessary analytical testing and stability studies.

Additionally it applies to clinical trials operations (Good Clinical Practice - GCP) and safety/toxicology studies (Good Laboratory Practice - GLP).

FinnBrit Consulting can advise on all aspects of cGMP pertaining to medicinal products and APIs.

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