Personnel Qualification in Aseptic Areas


The assurance of the consistency, accuracy of the process is evolved through the process of the validation, Hence the validation plays a vital role to have the assurance over the process.
In general during the qualification process, the process or the elements of the process are challenged with the stringent conditions and the satisfactory output of the same is ensured. The scenario is simple as far as the qualification of the equipment is concern, wherein the equipment is challenged with the test parameters and comparison of the expected output over the actual output is compared.

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Thank you another nice article, I have printed out and given to our cleaning validation team.

After passing in the acceptance criteria the candidate is put on the job for the visual inspection
what is the criteria ?

Good Question,
The acceptance criteria as per KNAPP test is 96 % for visual inspection.