In my opinion, it would depend on the company. Original validation would expire because changes are made within equipment and those changes need to be validated to assure that the equipment will produce accurate results. It would be a on a case to case bases. For example, a mass spec used in a major product would not need to be re-validated. However, if a machine has a part that has been modified or an additional part has been added, than it would need re-validation. Also, at some time your validation will expire because FDA doesn't approve things for life. New discoveries are made, consumer reports, and other factors will cause re-validation of equipment.

I don't believe there is really an expiration date for a validation. Each installation qualification process gets updated every year or so. Due to this, it accounts for any changes that may occur in terms of technology, new specifications, and new parameters. Also, if there is a deficiency that occurs with the product this would certainly create a need to update the validation procedures and revalidate the process. So, to your point I don't believe a validation has an expiration date because there are always going to be updates and changes occurring.

That a good question and it could be slightly trivial to answer. I believe that the original validation would not expire, but lets says there is a gap between the validation such as let's say that you just did an installation qualification and process qualification on a new equipment, 30 yrs later you look at the validation of the equipment and notice that an OQ was never addressed, but aspects of the OQ were covered within the IQ. From my experience you would look at the validation as if it meets the standards " of the day" since 30 years ago operation qualifications may have not exist but the IQ of the day slightly addressed one. You may need a memo from quality engineering that may have to be signed off to state that the validation package met the specification of " the day". Unless of course in the course of the 30 yrs the equipment was modified then maybe re-validation may be needed or a verification.

Chris

Hi All,

This is a very interesting question that I had not thought about before. As was mentioned above if any changes, upgrades, or repairs occur on a machine it would need to be re-validated. However if no changes were made and the equipment was simply kept calibrated and regular maintenance was done, there should be no need for re-validation. If a piece of equipment has not gone through any changes it would seem it would not need a re-validation; however I believe that most companies would put a time stamp on validation, ensuring that yearly or quarterly the equipment is re-validated.

-Andrew Nashed

Revalidation is required when the equipment is modified,relocated,or otherwise changed in a manner which may effect the process.Any change in the equipment need to be evaluated to determine the potential consequences on validation status.The Revalidation may be required based on observed performance of equipment eastablished initial validation ,as long as routine process operate in a state of control and no changes have been made to process,equipment may not have to be revalidated.Depending on their usage equipment have to be calibrate on a monthly,quarterly.or semiannually basis.calibration ensures that equipment can be used safely and reliably.

This is a very interesting point to bring up. As others have mentioned, revalidation is necessary when the product or device has been modified or updated from the original design. However, if there are no changes and the device is functional, then there is no need for revalidation of the product. However, the original validation would make sense to expire at some point. There is no exact duration that the original validation can be useable. The expiration of the original validation would be determined appropriately according to the product itself. In addition, another reason a revalidation would need to occur is if there is a change in the validation process itself. If there is a step added to the validation process, it is important that the products are revalidated. If not, then they will not follow protocol and become outdated. The validation process is a very important developmental stage for products or devices and should be maintained.

Some critical-process standards include a requirement for re-validation at "defined intervals", and to require that those "intervals shall be justified". (Language of ISO 11135-1, EtO Sterilization.)
It is common in the US device industry to regard the outer limit for 11135 re-validation as three years, with a maximum interval of one year between justification analyze (I have seen some places have their interval as "1 year"). Other validation requirements do not mention periodic re-validation. The purpose of this periodic validation verifies that the validated state is not compromised by any change that was not properly identified or evaluated.
Thus, to answer @Fady Khalla's question: yes, it is necessary and it depends on the nature of the process and the applicable standard.

Quote from FDA's Guideline
"The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation"

I think re-validation is required or not depends on the product. So, you need to ask some questions about your medical device, is it something like class I devices, like tongue depressor for example, or it is a class III medical device ?. Validation process cost a lot of money sometimes. However, re-validation might be required, depends on the market changes, or the performance of the medical device.
Re-validation process done every two years for some companies.

I agree with your justification but to take a step further, I believe the reevaluation should be done as often as possible. Granted a full reevaluation can be costly and unnecessary but it can be preventative for future issues. Just how reevaluations are done at specific time intervals and during recalibrations, I also think that it should be done as the user of the device changes. Again not as the full scale, but a smaller set of evaluations that can ensure proper function with each user. Also, a revolution of the setting and space around machinery should be done.

I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes to the fixture than the original validation is still valid. The only instances that I can see a need for a revalidation is if an engineer notices that the validation does not meet the company standards after the 30+ year timeframe. A medical device company is always updating the way they document and validate a process or equipment. So, if the company decides to update all validations to a new format then I can understand the need for revalidation. Other than that, if the fixture has not changed and is operational then there is no need for revalidation. The fixture is maintained per preventative maintenance and calibration dates.

It would vary with each company, but even if the equipment does not go through the entire validation process again, it does have to keep up with calibration expiration as well as preventive maintenance at scheduled intervals. With these routine fixes, the system would never fall too far out of validated conditions.