Validation of the commercial manufacturing process is one of the key deliverables for getting the marketing authorization (approval) of a drug. In the past, validation of commercial manufacturing processes comprised three validation batches and was then considered complete. Since 2011 however, the expectations by regulatory authorities with respect to validation changed. Process validation should be an ongoing effort and should continue during commercial manufacturing. This is also known as “Continued process verification” (CPV).

The CPV program is based on gained process knowledge derived during the design of the process and the qualification/validation of the process. An important part of a CPV program is the monitoring of the commercial manufacturing process. For this purpose process data are collected followed by statistical process control (SPC) analysis of the data. Based on the data analysis it can be determined whether the manufacturing process is in a state of control (validated state). By monitoring so called process inputs such as Critical Material Attributes (CMA) and Critical Process Parameters (CPP) it is possible to minimize process variability. If necessary the manufacturing process can be adjusted to ensure that the results of so called process outputs, such as Critical Quality Attributes (CQA), process times and yields will met the predefined quality requirements.

Next to the monitoring of the commercial manufacturing process, statistical process evaluation is also part of the quality system. The results of the data analysis are an important source to determine the robustness of the process, the impact of process deviations on product quality and the efficacy of implemented CAPA’s (Corrective Action Preventive Action) and changes. In addition, they support analytical method and process technology transfer and support implementation of process optimization

How can we help you with Continued Process Verification?

Progress experts have extensive knowledge of designing a CPV program for new as well as for legacy products. Their broad expertise comprises writing and implementation of CPV and SPC policies, performing of (daily) statistical process control and the interpretation of the results.

Our approach

We combine our CPV knowledge with our state of the art process validation knowledge to support you to produce drug products which fulfil all quality requirements during the whole lifecycle of the drug product.