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Process Validation

Process validation is regarded as a pivotal activity towards assuring pharmaceutical product quality and demonstrating the capability and robustness of the various processes involved. The roots of process validation lie firmly in product development, when critical process parameters and acceptable process ranges are established either at the laboratory or pilot scale. As the product moves forwards into late development, further process validations are required to address scale-up or transfer issues. Process validation is generally regarded as complete when the so-called consistency lots are manufactured, which demonstrate the reliability of the process when installed at the final scale and in the commercial environment. 

There is no doubt that process validation is a costly exercise in terms of resource, material and time requirements. Furthermore, it is a critical success factor for timely market authorisation approvals. For this reason, a good strategy of process validation which is well designed, timely and appropriate is essential.

Not only new processes are expected to be validated. The traditional acceptance of retrospective validation for established processes is also being increasingly questioned by the Regulatory Authorities. Consequently, there are additional challenges emerging associated with the application of modern process validation principles to well-established products.

 

HPCS can provide strategic and practical support in all aspects of process validation, both pre- and post-market authorisation. In particular, the following services can be provided:

• Process mapping and risk assessments to determine validation requirements.
• Preparation of Site Validation Master plans and project Validation Master plans.
• Development of project-specific validation protocols, reports and validation summaries for Regulatory submissions (MAA, NDA).
• Systematic review of validation documentation for compliance to cGMP and / or Regulatory requirements.
• Analytical support for completing process validation and cleaning validation studies.
• Preparation of Comparability Protocols (EU and US FDA type) for validation of process changes (pre- and post-approval), scale up or transfer.
• Developing retrospective process validation strategies as well as concurrent validation studies for established processes.
• Preparation of Annual Product Quality Review (APQR) documentation as a basis for ongoing retrospective process validation review to meet current US FDA requirements and imminent EU expectations.

With its team of experienced process engineers, pharmacists, microbiologists, chemists and Regulatory Affairs specialists, HPCS can provide full project support to most process validation requirements.