Validation is well-documented proof with a high level of confidence that a system, equipment, software, test method, drug manufacturing, sterilization or cleaning process will be consistently and robustly delivered, providing a result that meets the requirements of predefined specifications in approved validation protocols.
The purpose of the validation process is to ensure that a pharmaceutical product meets all quality, efficacy and safety requirements that have been set for the final product, during all stages of production and in different batches of the same product, while adhering to a controlled and documented process.
Validation processes includes a validation plan (VP), risk assessment, system design or design qualification (DQ), installation qualification (IQ), operational qualification (OQ), system performance qualification (PQ), production process qualification (PPQ), and validation of cleaning processes, software and control systems and repeat/periodic validation.
