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.
A documented program that provides a high degree of assurance that a specific product, method, procedure (e.g., cleaning), or system will consistently produce a result meeting predetermined acceptance criteria. [1] [8] [13] [16] [19] [20] [23]
Contains starting materials of plant origin.
The application of methods, procedures, tests and other evaluations to provide objective evidence that the output of a particular operation meets the specified requirements for that operation. [1] [14] [20] [23]
Validation Master Plan
Validation Protocol
Validation Report
