Establishing Acceptance Limits for Probability of Passing Multiple Stage Tests in Process Validation through a Process Capability Approach

Cholayudth, Pramote
November 2009
Journal of Validation Technology;Autumn2009, Vol. 15 Issue 4, p77
Academic Journal
The article discusses the use of process capability index (CpK) in pharmaceutical technology, as well as the use of probability of passing multiple stage tests and how to determine their acceptance limit. It is computed to measure the degree of data consistency in process validation. However, its limitation to communication the exact meaning is of its disadvantages. A high chance of conforming to the specification for a quality control (QC) sample may be generated by a product lot of good quality. A CpK limit of not less than 1.33 may be employed in validation in single stage tests.


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