The following is an edited excerpt taken from The Windshire Group’s webcast Validation: Tried and True Success Lessons from the Front Lines Expert Panel Discussion-LIVE FREE Webcast.
James Blackwell, Ph.D., M.B.A.: Validation provides documented evidence to support your claims around the robustness and quality of your product. As such, it is an extremely serious testing exercise that receives close scrutiny by the authorities and for good reason. And so, when you are thinking about conducting your validation, you should carefully consider how best to construct your validation protocols, your plans, and executing those protocols. When there are deviations, they need to be documented correctly and justified appropriately. Results that do not meet the acceptance criteria obviously will need to be investigated. You need to ensure that the appropriate rationale supports the validation and your process is validated.
I had a client situation where the FDA came in and looked at what had happened during validation and then stated, “I do not think your processes are validated,”, and that is not a good position to be in. And it is not just about the technical aspects. If you have a batch that has 20 significant deviations that occur during execution, your process is not in control and therefore not validated.
Related to the three phases of validation (process design, process qualification, and continued process verification), I think now most organizations have shifted towards this three-phase view that really continues on after your process qualification and into continued process verification. And again, that is an area where companies I think struggle to get up to speed because they do not have the appropriate software solutions and the supporting quality system in place; and monitoring to be able to handle the requirements of continued process verification.
The FDA’s Guidance for Industry : Process Validation: General Principles and Practices is an invaluable reference resource. Process validation is defined in this document “as the collection of evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Effective validations should produce a product that is fit for its intended use and that quality, safety, and efficacy are designed or built into the product.
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