Continued Process Verification
Validation of the commercial manufacturing process is one of the key deliverables for obtaining a marketing authorization (approval) for a medicinal product. In the past, validation of commercial manufacturing processes involved three validation batches and was then considered complete. However, since 2011, regulators’ expectations regarding validation have changed. Process validation should be an ongoing effort and should continue throughout commercial manufacturing. This is also called “Continued Process Verification” (CPV) as outlined by the US Food and Drug Administration (FDA) in the Guidance for Industry Process Validation, or “Ongoing Process Verification” (OPV) according to the EMA terminology.
The CPV program is based on process knowledge acquired during the design of the process and the qualification/validation of the process. An important part of a CPV program is monitoring the product and commercial manufacturing process. For this purpose, product and process data is 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 and controlling 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, meet the predefined quality requirements.
In addition to monitoring 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 effectiveness of implemented CAPAs (Corrective Action Preventive Action) and changes. In addition, they support analytical methods and process technology transfer and support the implementation of process optimization.
How can we help you with Continued Process Verification?
Progress experts have extensive knowledge of designing a CPV program for both new and legacy products. Their broad expertise includes (technical) writing and implementing CPV and SPC policies, performing statistical process control and interpreting the results.
Our approach
We combine our CPV knowledge with our state-of-the-art Process Validation knowledge to support you in producing drug products that meet all quality requirements throughout the entire life cycle of the drug product.
