Status of a GMP relevant system or process that is achieved after having provided documented evidence that the system or process is capable for the intended use in the manufacturing of pharmaceutical excipients.
Validation is a process required by the pharmaceutical industry for API and finished medicinal product. It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. There are several ways to confirm that the requirements which define an intended use or application have been met. For example, you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them.d acceptance criteria. [42]
A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters and operating ranges, product characteristics, sampling, test data to be collected, number of validation runs and acceptable test results. [21]
Contains starting materials of plant origin.
Verification is a process more commonly used by excipient manufacturers. It uses objective evidence to confirm that (the) specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. [42]
Validation Master Plan
Validation Protocol
Validation Report
