Using Process Validation to Ensure Quality

Pharmaceutical Technology spoke with Archana M. Akalkotkar, PhD, research scientist I at Charles River and a member of the Contract Research Organization focus group in AAPS, about how companies can use process validation to ensure the quality of their product.

PharmTech: What are some of the tools that can be used to ensure process and product quality?

Akalkotkar: One of the most important tool to ensure the process and product quality is developing an appropriate quality program depending on the needs of the company. The model for quality should meet the needs and culture of the target audiences. Implementation of set of techniques and tools for process improvement including Six Sigma, lean methodologies, root cause analysis, failure modes and effects analysis, or health failure modes and effects analysis (HFMEA) could help to better streamline the process.

PharmTech: How can companies integrate the various regulatory documents/requirements into a comprehensive process validation approach?

Akalkotkar: Companies should follow the regulatory guidelines for process validation. The cGMP regulations require that the manufacturing processes be designed and controlled. If the guidelines are not available for a particular process, efforts should be put in to identify the key parameters that affect the process validation. These key points should be further drafted into a white paper to harmonize the practices for process validation in the companies.

PharmTech: What are the most crucial aspects of process validation and why?

Akalkotkar: Some of the crucial aspects of process validation are the process design, its qualification, and continuous verification of the process. The process design step allows for creating a process that has the ability to constantly produce quality material. Process qualification identifies the acceptance criteria for the outcomes and confirms if the current process design is capable of delivering reproducible quality products. The last step of continuous process verification is important to make sure that the current process is reliable and the processes are running in a controlled manner.