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, the amount of practical problem microorganisms inside the product is approximated at different time intervals by calculating the concentration of cfu per mL via the plate count method. A structure for validating neutralization would integrate the therapy teams as described below Validation of Neutralization Methods—Restoration Comparisons.Be
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QA Head shall review & accepted process validation protocol, approve validation report for its completeness and correctness with respect to all facts and report, and to be sure implementation of SOP.Accomplish the PV of only Mixing Procedure and judge the extent of validation study of other phases according to the danger/impression assessment.Verif
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