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Validation study activities can be classified into three phases:
Phase 1: Process Design
This step is where the process of building and capturing knowledge and understanding takes place. At this stage the preliminary design of the process and experiment should be done. It covers all activities related to product research and development, formulation, pilot batch studies, scale-up studies, technology transfer to commercial scale batches, establishment of stability conditions, storage and handling of in-process and finished dosage forms, equipment qualification, installation. Qualification, Master Production Document, Operational Qualification, Process Capacity. It is also the phase where a strategy for process control is being established using the accumulated knowledge and understanding of the process.
Stage 2: Procedural Qualification
This phase ensures that the process design is capable of reproducing the manufacturing process. This ensures that all established limits of critical process parameters are valid and that satisfactory products can be manufactured even under “worst case” conditions. This phase must follow GMP compliant procedures and successful completion of this phase is required before commercial distribution of a product.
Related: Process Validation
Phase 3: Continuous process validation
The validation maintenance phase requires frequent review of all process related documents, including validation audit reports to ensure that there are no changes, deviations, failures, changes in the manufacturing process and that all SOPs including change control procedures are followed.
Before distributing a batch for marketing, the manufacturer must have full assurance of its efficacy. A successful validation program depends on knowledge and understanding and methods of controlling the manufacturing process. These include sources of variation, limitations of variation detection, and characteristics sensitive to variation.
It is the manufacturer’s responsibility to judge and provide evidence of a high level of assurance in its manufacturing processes. They are also responsible for maintaining a level of assurance even when minor changes occur due to personnel, material and process changes.
