just like any other process, vaccine manufacturing procedures are defined as a series of interrelated functions and activities using a variety of specified actions and equipment designed to produce a defined product. to assure the reproducibility and consistency of such processes, they must be carried out using validated equipment and under the established procedures that meet all the acceptanc...

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...

abstract: An analytical method validation represents a complete investigation of the materials’ properties, following certain steps, being necessary for “proving the fit for purpose of an analytical method”. The validation procedure demonstrate that a defined validation protocol for an analytical method applied to a specified testing material and a defined concentration of the analyt – named an...