Preliminary Analysis of the Process Validation for Orally Solid Drugs

The objective of process validation, the precondition of process validation, the protocol and report of process validation are introduced in this paper, tablets are taken as an example for detailed illustration. Process validation is the documented evidence that a process is capable of consistently delivering quality product. The manufacturing process should be understood well before process validation. Validation protocol is a document that specifies how validation of a particular process will be conducted. Validation report is a document that summarizes and evaluates the results obtained.