Why process validation

The production process of pharmaceutical products is subject to strict regulations such as GMP. Qualitative continuity is central to this. The law obliges manufacturers to provide documented evidence that the process yields a product that continues to meet the proposed requirements. Process validation is, therefore, crucial in any new process or any amendment to an existing production process.

The requirements regarding process validation are described in the GMP (Good Manufacturing Practices) and several Guidelines on process validation. Apart from the legislative need, process validation guarantees the producer and consumer a process in which patient safety, product quality and data integrity are key.

What and how?

Process validation starts from the process design and guarantees the stability of the product throughout the entire product life cycle. Each partof the process is evaluated separately and forms an integral part of the final assessment of the process. This may include equipment, materials or software.

In order to get stability in the production process it is fundamental to detect and address any deviations. Producers need to know the presence and frequency of deviations, as well as the cause and its impact on the end products. Our process validation approach allows us to map this thoroughly and provide quality documentation (Process Qualification). Process validation is a continous process that needs to be continually adjusted as new production information becomes available (Continous Process Verification).

The process validation plan includes:

• A brief description of the process with an overview of the critical process steps or critical process parameters which are monitored during validation;
• Details of the analytical methods;
• Sampling plan – where, when and how are samples taken;
• Timetable;
• Etc.

Why agidens for process validation?

• Our way of working is based on a ‘quality by design approach’.
• We have extensive experience with process validation of complex and extensive production processes.
• We carry out the process validation for both sterile and non-sterile processes.
• Our approach ensures that the processes comply with EU and FDA regulations.
• We can provide an integrated team with expertise from all relevant disciplines such as process engineering, quality assurance, production, etc.