Before a manufacturing process can be validated, a state of control must be established. Attempting to validate a process without the proper foundation is not only a regulatory deviation but a significant business risk.
The following are the critical prerequisites that must be in place before initiating a process validation exercise (specifically Stage 2: Process Performance Qualification):
1. Qualification and calibration of the equipment’s, facilities and utilities are involved.
2. Validated/verified analytical methods shall be used.
3. All materials and suppliers used for validation must be approved or qualified.
4. Personnel performing process optimization/validation activities must be suitably trained and training records to be available.
5. Approved standard testing procedure (STP) and specifications.
6. Approved master batch manufacturing record, master batch packaging record, and bill of materials (BOM).
7. Approved validation master plan (VMP) and protocol
8. Process development and scale-up package containing critical process parameters and control strategy.
Ensuring these prerequisites are met guarantees that the validation exercise is a true test of the process's capability, rather than an investigation into fundamental flaws in the system or facility.
Read also: Number of Process Validation Batches Before Product Release
