What are the key differences between prospective, concurrent and retrospective validation?

In GMP, prospective validation is important. It means checking a process or system before using it, identyfying and fixing issues upfront. It follows a step-by-step plan for new processes or big changes, ensuring they meet quality rules. This proactive check keeps manufacturing safe and controlled, meeting standards from the beginning—a important step in assuring product quality and safety

The difference is that retrospective validation should not be used anymore….industry had enough time to deal with old processes

Prospective validation is a critical component of quality risk management and an essential prerequisite for ensuring robust processes and systems. By proactively identifying and mitigating risks upfront, prospective validation enables organizations to avoid costly failures down the line. While requiring more planning and effort early on, the long-term benefits greatly outweigh the initial resource demands. Prospective validation should be embraced as an opportunity to build quality into processes and systems from the ground up, rather than an added burden. When performed diligently according to structured protocols, it provides ongoing confidence in the suitability and capability of processes to consistently deliver quality outcomes.

Prospective is more along the lines of equipment Qualification. The intent is to ensure the equipment is "fit for intended use" before we use it. Commissioning should be to install the equipment, or system, bring it online and do shakedown testing to dial it in. Qualification should be to document that the equipment meets the URS Requirements, then we move into Validation. This also brings up the need to ensure the URS is properly designed to show what the user needs, and not just regurgitate the cutsheet for the equipment we already have on order.

Concurrent validation involves assessing the performance of an existing method or process using simultaneously collected data. The key characteristics of concurrent validation are: - Purpose. - Study Design: No specific study design is required, as the method or process is already in operation. However, data collected during routine use is analyzed retrospectively. - Timeframe. - Data Collection. - Decision Making: The validation results help to confirm or revise the suitability of the method or process for ongoing use. -Documentation: involves gathering and analyzing data from routine use to evaluate the method's performance.

Retrospective validation is a useful method; However, this approach may not be the most suitable for high-precision industries such as aerospace, automobile manufacturing, or the medical device industry for several reasons. For example, critical safety standards, complexity of systems, regulatory requirements and precision...etc.

Retrospective validation is a very useful method and is often not utilized to its full potential. AI will be a very powerful asset in the future as it can comb through the datasets with ease.

Process validation demonstrates the adequacy of the manufacturing process through: Process design: Prcess Design improves product & process understanding to define control strategy throug Critical Quality Attributes (CQAS) and Critical Process Parameters (CPPS), Process qualification: Personnel, premises, utilities, support systems and equipment should be qualified perior to process validation. Performance Qualification should be done by the same people who will carry out normal operation at routine conditions. Continied Process Verification: Monitoring of product quality for commercial batches after completion of process design and process qualification to verfy state of control is maintained throughout the product life cycle.