Performance Qualification provides documented evidence that the integrated system or process is capable of consistently producing the intended product in a high quality and safe manner.
The PQ documents and provides objective evidence that a process consistently operates with in predefined acceptance criteria.
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The Bayes Success-Run Theorem is as follows: R = (1-C) ^ (1/n) where: R = Reliability (or probability of success) C = confidence level n = sample size for "0" failures allowed on test Transposed the formula becomes n= ln(1-C)/ln(R) For example, if we want to be 95% confident that a process is 95% reliable how many parts do we need to produce that are defect-free?
n= ln (1-.95)/ln(.95) = 59 parts with "0" failures allowed on test (note: always round up to the next whole number) Now the question becomes: what confidence and reliability level should be used to determine the appropriate sample size?
Prior to performing process validations, it is important to have well defined and documented specifications and acceptance criteria.
Additionally, a well documented engineering study (design of experiments) should be conducted to find the operating window that defines the combination of parameters which when utilized, will consistently produce products within the allowed specifications. There are several factors that must be considered when determining the appropriate sample size including risks associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing.
Sampling plays a major role in achieving the accurate results of analysis.
Sampling plan and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activity starts. So it should be homogenous and should be taken properly from appropriate locations.
Installation Qualification verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications.
Additional information is usually generated at this time including generation of a recommended spare parts list and maintenance schedule.
Although process validation is not the top observation category, it is very significant and should be addressed to ensure compliance.