Process Validation Lifecycle Approach in Pharmaceutical Manufacturing
The lifecycle approach to process validation has become the global standard, incorporated into guidelines by the US FDA, EU, and WHO (See TRS 1019, Annex 3, Appendix 7). Since WHO GMP guidelines apply to Bangladesh, this approach is equally relevant to our pharmaceutical industry.
What does this mean for us?
Process validation is no longer a one-time activity; it’s a continuous journey ensuring product quality and patient safety. The three key phases are:
Process Design – Understanding and developing a robust manufacturing process.
Process Performance Qualification – Confirming that the process can produce consistent quality at a commercial scale.
Continued Process Verification (CPV) – Ongoing monitoring and control to ensure the process remains in a state of control.
Before any batch from the process is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce APIs and drug products meeting those attributes relating to identity, strength, quality, purity, and potency.
The assurance should be obtained from objective information and data from laboratory-, pilot-, and/or commercial scale studies. Information and data should demonstrate that the commercial manufacturing process is capable of consistently producing acceptable quality products within commercial manufacturing conditions.
The following practices should ensure uniform collection and assessment of information about the
process and enhance the accessibility of such information later in the product lifecycle.
- An integrated team approach to process validation that includes expertise from a variety of disciplines (e.g., process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance). Project plans, along with the full support of senior management, are essential elements for success.
- Throughout the product lifecycle, various studies can be initiated to discover, observe, correlate, or confirm information about the product and process. All studies should be planned and conducted according to sound scientific principles, appropriately documented, and approved in accordance with the established procedure appropriate for the stage of the lifecycle.
- With a lifecycle approach to process validation that employs risk based decision making throughout that lifecycle, the perception of criticality as a continuum rather than a binary state is more useful. All attributes and parameters should be evaluated in terms of their roles in the process and impact on the product or in-process material, and reevaluated as new information becomes available. The degree of control over those attributes or parameters should be commensurate with their risk to the process and process output. In other words, a higher degree of control is appropriate for attributes or parameters that pose a higher risk.
- Many products are single-source or involve complicated manufacturing processes. Homogeneity within a batch and consistency between batches are goals of process validation activities. Validation offers assurance that a process is reasonably protected against sources of variability that could affect production output, cause supply problems, and negatively affect public health.
Read also: