Friday, March 2, 2018

Why Validate?

Similar to what the FDA has imposed in the pharmaceutical, biopharmaceutical and medical equipment industry, the food production sectors must validate the production processes of high-risk foods to ensure that all systems have a consistently high level of assurance to produce a product that consistently meets the pre-designed specifications. This gives a company a control system that is consistent and reproducible.  Furthermore, a validated process is credible and stable, because the acceptance criteria are already specified in the qualification phases of the validation.
If the specifications of the system, how it is designed and how it works are known, it will be possible to maximize the performance of that system.  If the validation is carried out correctly and with the right objectives, it can be a process with added value for the company.

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Pharmaceutical Validation Documentation Requirements

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