Difference of verification and validation -
Verification is an evidence that establishes or confirms that the system or process meets its intended use at a single point in time. Whereas for validation, which is a documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.
Oh this is a very commonly misunderstood thing. For starters, verification is the act of verifying each time the process is run that all parameters were met and testing for the release. Validation is the process of demonstrating that you have control over you process to show that it is repeatable by monitoring key process parameters that will show when there are problems that would impact the product quality. It is feasible to have a process that does not get validated and is in a state of verification. This would be rather lenghthy and expensive, but if the process is not easily demonstrated to be repeatable, then this is an option (ie manual cleaning). The problem a lot of people face is that they try to validate without a solid scientific understanding of their process and try to find those parameters on the fly.
Verification and Validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system. Verification is intended to check that a product, service, or system (or portion thereof, or set thereof) meets a set of initial design requirements, specifications, and regulations. In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results. In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production.
Validation is intended to check that development and verification procedures for a product, service, or system (or portion thereof, or set thereof) result in a product, service, or system (or portion thereof, or set thereof) that meets initial requirements, specifications, and regulations.Validation is intended to check that development and verification procedures for a product, service, or system (or portion thereof, or set thereof) result in a product, service, or system (or portion thereof, or set thereof) that meets initial requirements, specifications, and regulations. The focus of the validation performance is the ripetibility while for IQ and OQ test isn’t required.
So let me get this straight, if we Validate the process we do not need the IQ/OQ? Somehow I hope this is not your interpretation of the newer guidance that has come out in recent years. The qualification of the equipment to be “fit for intended use” is still very critical, but it has been given some leeway to able to conduct those efforts in conjunction with the commissioning. This actually helps to reduce the load of the non-conformances since there should be some wiggle room to fix the problems and make the equipment work properly. It is a good concept as described in the ASTM E2500 as well as the ISPE guidance on Science and Risk Based commissioning and Qualification. The latter is almost a complete roadmap on how to set the program up (side note, I am not a member of ISPE but a huge fan of this work).
When we talk about Validation under the current thinking from the agency, we are referring to the effective demonstration of our scientific understanding of our process and the ability to monitor and trend certain process parameters that could impact the product SISPQ. As stated earlier, verification is testing the product for release each time to show that the product meets its standards. This is a viable option, but not highly reccommended.
Probably I haven’t explained well.
IQ and OQ are still needed in the initial qualification and in case of changes involving the equipment / system. The PQ is done routinely in the case of machinery or critical systems and inevitably requires the three runs to confirm the “reproducibility”. The verification is still an essential support to monitor the periodic (annual or biannual) qualification status of the systems / equipment.
The texts from which to draw to the validation guidelines are really many (PIC / S, WHO Guidelines, ISPE GMP Guideline, EU Legislation Eudralex, FDA guides, PDA and more), but the important thing is to follow the approach best suited to the product that you do in your business keeping the best required quality standards.
At disposal for any clarification.
In accordance with the FDA guidance for process validation, it is not appropriate to just do 3 runs and call it a validation. There needs to be enough process understanding and scientific data to support your justification for the number of runs you do. It is also expected that you have enough process understanding to establish effective CPP’s and CQA’s and going forward you can continuously monitor the process to detect any changes in the process that would impact SISPQ. Please seek out the current guidance and have a good read. Following tradition will only keep me in business, but I would rather see it done right.