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dear all,

is it necessary to revalidate the validated process after two or five years again if there is no change or revalidation is not required on the basis of retrospective data of the product through apqr?


No, it is not required to revalidate on a time bases, unless it is stipulated in your company validation Practices and Procedure documentation.

Alex Kennedy

It is worth noting however that the new draft FDA PV guideline explicitly states that a lifecycle approach is now a requirement for process validation. A periodic review of your process data will be used to assess whether revalidation may be required. This will be done on a case-by-case basis, although no specifc timeframes are given.

Dear All,
I have one more query regarding re-validation. Is it necessary to re-validate the process for change in euipment, where the make, model, capacity remains the same? If no; then how it is justifiable.

If you change a piece of equipement that is critical to the process then you would need to revalidate to show that the new equipment produces results within your predetermined specification. Just because it is the same make and model does not mean it is idential. A good example of this can be find here:
on page 5 the section is titled “Validation and equipment qualification;when “identical” really isn’t.”

Thanks for your reply and the attached link.

But suppose if the process is not revalidated for change in equipment with similar make, model, capacity and principle; then are there any regulatory concerns? suppose if a risk assessment is performed, then can it be justified to regulatory authorities?

My first question would be what does your SOP/Company Policy/Master Validation Plan state for validation of new equipment? That is where I would look first for what to do in that situation. However, from my experience it is standard industry practice to validate all new equipment. If you only do a risk assessment a FDA inspector could say the assessment is not satisfactory and make you validate and/or make you recall all products released to the public on that machine because you do not have a controlled process.

To further bring my point to a close, I would say look at SEC. 501. [21 USC 351] Adulterated Drugs and Devices of The Act. Which states, “if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;”

I hope this helps.

Regarding seal’s comment: It’s been my experience that, indeed, re-validation is necessary any time such a change is made. However, it doesn’t have to be a full re-validation. A careful (and documented) analysis of the change can be used to limit the scope of re-validation.

Regarding rohininair’s last post: I have not seen a case where a risk assessment has been used to COMPLETELY eliminate re-validation. I wouldn’t want to try to defend it.

Yes, I fuly agree with yodon. Re-validation is required in following cases,

  1. Chage in validated system/process
  2. Repeate trends of failures
  3. Shifting of validated equipment within site from one location to other.

Extent of re-validation can be decided on the basis of reisk assessment.

I agree with Harsh. The fact is that should you re-validate/qualify every 2,3 or however many years, the first question that an auditor would ask is, " Do you not trust your systems enough that you have to control it in this way-out, costly and time consuming manner?"

If you dont trust the systems then by all means add it in to your plan, otherwise, dont do it.

Hope this is of some help.