VERIFICATION STRATEGIES FOR ESTABLISHING RELIABILITY AND VALIDITY IN PHARMACEUTICAL MANUFACTURING PROCESS- AN ENROUTE TO REGULATORY COMPLIANCE

The Process validation involves a series of activities over the lifecycle of the product and process. The FDA guidance described three stages of process validation which includes Process Design, Process Qualification, and Continued Process Verification (CPV). The CPV stage is a never ending approach that continues throughout the entire commercial lifecycle of the product. CPV is dependent on compliance with GMP principles and ensures that manufacturing process remains in a state of control. Establishment of Critical process parameters (CPP) and assessment of Critical quality attributes (CQA) of a product ensures robust manufacturing process and thereby improves productivity and desired quality. The product stability program, change control process & annual product review process serves as key drivers for monitoring process stability. Process analytical technology (PAT) applications such as near infra red spectroscopy, raman spectroscopy & multivariate statistical process control can be viewed as enablers for CPV. The primary goal of PAT is to reduce process variabilities that may impact CQA’s of a product. Continued Process verification is an effective quality risk management tool for detecting trends and implementing preventive measures prior to CQA failures. Conducting a gap analysis helps to detect discrepancies related to manufacturing process, quality control systems of a pharmaceutical industry and becomes mandatory to achieve regulatory compliance. Ensuring data integrity is an essential component of industry’s responsibility to ensure safety, efficacy and quality of drugs and is a direct measure to protect the public health.