Testing From Drug Substance To Final Product

摘要

That completes a general overview of the types of tests and monitoring activities associated with the formulation and F/F of purified bulk drug substance to final drug product. Although the overall process is fairly straightforward, it can be easy to over-test, especially during formulation activities. Keep in mind these key points: Test only when necessary to reduce interventions; test using methods that give data as quickly as fittingly possible to condense processing times; and utilize a client's knowledge of the product and the contractor's knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.