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06.11.2014
Using all of the above analysis techniques, knowledge of the process and agreement on by a cross-discipline committee, acceptance criteria ranges can be assigned for the critical parameters and attributes. Since the ideal case of validating a process during its implementation does not always exist in the pharmaceutical, biopharmaceutical, biotechnology or medical device industries, it may be important to determine a way to validate these processes using historical data. Therefore this range may be appropriate to use as acceptance criteria based on the statistics.
When selecting the acceptance criteria, a cross-functional committee should be utilized with backgrounds of QA, Manufacturing, Validation, R&D, and Engineering present. This should be done prior to a final agreement on the range and incorporation into the validation protocol.


A cross-functional team should perform a risk assessment on the parameters and attributes to determine which ones would be included in the process validation. A report should be written to document the ranges with the rationale for selecting them and the justification for determining the limits as well as any determination that the ranges are within the PAR. A range establishing study for the attributes and parameters should be performed to evaluate historical data and analyze the data set for the concepts of normality, variation (standard deviation), and confidence. Additionally, those ranges which are not to be included should be discussed within the report to justify why they are not to be recorded. With a high degree of confidence, acceptance criteria ranges should be set for each parameter and attribute and a process validation protocol should be written with the appropriate ranges.


A process validation protocol should be prepared with theses ranges for acceptance criteria and the process should be run at a target within the acceptance criteria ranges at least three consecutive times using identical procedures to verify that the process is valid. This protocol should be approved and executed at target settings within the acceptance criteria ranges, from the start of the manufacturing process to the finish using qualified equipment, approved SOPs, and trained operators.
In a final report for the process validation, the degree to which the process is valid would be determined by the satisfaction of the approved acceptance criteria.



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