Continued Process Verification As Per WHO TRS1019 Annex 3
Manufacturers should monitor the product quality of commercial batches after completion of process design and process qualification.
This will provide evidence that a state of control is maintained throughout the product life cycle.
The scope and extent of process verification will be influenced by a number of factors, including:
- Prior development and knowledge of the manufacturing of similar products and/or processes.
- The extent of process understanding gained from the development studies and commercial manufacturing experience.
- The complexity of the product and/or manufacturing process.
- The level of process automation and analytical technologies used.
- For legacy products, with reference to the product life-cycle process, robustness, and manufacturing history since the point of commercialization, as appropriate.
Manufacturers should describe the appropriateness and feasibility of the verification strategy (in the protocol), including the process parameters and material attributes that will be monitored, as well as the validated analytical
methods that will be employed.
Manufacturers should define:
- The type of testing or monitoring to be performed.
- The acceptance criteria are to be applied.
- How the data will be evaluated and the actions were taken?
Any statistical models or tools used should be described. If continuous processing is employed, the stage at which the commercial process is considered to be validated should be stated, based on the complexity of the process, expected
variability, and the manufacturing experience of the company.
Periods of enhanced sampling and monitoring may help to increase process understanding as part of continuous improvement.
Information on process trends, such as the quality of incoming materials or components, in-process and finished product results, and non-conformances, should be collected and assessed to verify the validity of the original process validation or to identify changes to the control strategy required.
The scope of continued process verification should be reviewed periodically, and modified if appropriate, throughout the product life-cycle.
Reference: Good manufacturing practices: guidelines on validation -Annex 3