Qualification and validation
Qualification and validation works are priority ones in pharmaceutical production and make up the foundation of GMP requirements. Qualification and validation provide the proofs of the replicability of the processes, системproduction support systems, engineering tools, etc. and of the fact that these actions lead to expected results, are under the producer’s control and correspond to the parameters set in advance.
As a rule, qualification is related to technical means, engineering systems, clean premises, etc. At the same time, validation usually covers the operations, processes, procedures and other action, where staff is typically involved. In order to prove that the production process really leads to desired results, it is necessary to first carry out the qualification of what provides this process and is connected to conducting it (premises, equipment, production lines, engineering production support systems, etc.).