Continued Process Verification (CPV) and Product Quality Review (PQR)
A continuous process validation, ongoing process improvements, and secure processes represent the core of reliable products. This is why, according to the FDA guidelines, a process validation is supposed to encompass the entire product life cycle.
By means of the Continued Process Verification, also named CPV "report", the product quality is meant to be assured in established manufacturing processes. The elements of a CPV report are similar to the Product Quality Review, also named PQR "report", which may be more familiar.
The CPV reports in the pharmaceutical industry represent a part of the process and product validation. Basically, the aim is to control and monitor the process variation and the variation sources. Besides descriptive statistics, the batch- or lot-related statistical quality management tools used for this are, for example, control charts, capability studies, and shelf-life studies.
From the very beginning, our customers are optimally supported in the implementation of the Continued Process Verification in their own company, by using the products of Minitab Inc., especially the statistical software Minitab and Companion by Minitab, as well as ADDITIVE's AQUA server.
Companion by Minitab, for example, can help to collect and structure the important attributes for the process and product performance and relate these attributes to each other, applying team and structuring tools.
The statistical software Minitab provides all statistical tools necessary to perform cause-and-effect analyses and introduce statistical quality analysis. The AQUA server connects automatedly the data of the important attributes with the relevant statistical analyses and, thus, enables an online-monitoring of established manufacturing processes and the creation of complete CPV reports.