IQ, OQ, PQ and Validation Master List

[Juan Dude]

At least under current FDA and 13485/MDD guidelines, how do you classify a process as validated without an IQ/OQ/PQ? Grandfathering applies for products, but I wasn't aware that it conceptually applied to processes.

The concept is called "Retrospective Validation".

 

[jbvalidates]

The concept is called "Retrospective Validation".

This is where I stand now, coming into a company that did not previously fall under FDA guidelines but now due to new changes in product, new products, and clients that we are manufacturing product for, we have to create a MVP, and need qualification documentation for pretty much everything. previously all that had been validated had been lab processes, some lab equipment, and compounding.

I had been reviewing possible retrospective validation for equipment that has been in place, but not sure where to start or what to do. Any help?

 

[Juan Dude]

This is where I stand now, coming into a company that did not previously fall under FDA guidelines but now due to new changes in product, new products, and clients that we are manufacturing product for, we have to create a MVP, and need qualification documentation for pretty much everything. previously all that had been validated had been lab processes, some lab equipment, and compounding.

I had been reviewing possible retrospective validation for equipment that has been in place, but not sure where to start or what to do. Any help?

It's really difficult to give specific validation advice without knowing the product/process details but here's some general info. hope it helps.

From FDA's "GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION":

B. Retrospective Process Validation

In some cases a product may have been on the market without sufficient premarket process validation. In these cases, it may be possible to validate, in some measure, the adequacy of the process by examination of accumulated test data on the product and records of the manufacturing procedures used.

Retrospective validation can also be useful to augment initial premarket prospective validation for new products or changed processes. In such cases, preliminary prospective validation should have been sufficient to warrant product marketing. As additional data is gathered on production lots, such data can be used to build confidence in the adequacy of the process. Conversely, such data may indicate a declining confidence in the process and a commensurate need for corrective changes.

Test data may be useful only if the methods and results are adequately specific. As with prospective validation, it may be insufficient to assess the process solely on the basis of lot by lot conformance to specifications if test results are merely expressed in terms of pass/fail. Specific results, on the other hand, can be statistically analyzed and a determination can be made of what variance in data can be expected. It is important to maintain records which describe the operating characteristics of the process, e.g., time, temperature, humidity, and equipment settings.(11) Whenever test data are used to demonstrate conformance to specifications, it is important that the test methodology be qualified to assure that test results are objective and accurate.

Source: FDA's "GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION"

 

[jbvalidates]

Thanks for the information. That is mainly what I have found so far, just was not sure if it was sufficient. We mfg soaps and lotions, just recently with a medicated line and with a claim of 99.9999% germ efficiency.

 

[jbvalidates]

another question- Qualifying equipment that has been in place for YEARS....where/how to start collecting documentation, and qualifying it, rarely has anything been saved for this purpose. and how much detail does the MVP need to go into, any templates or samples for that?

 

[v9991]

1)
for retrospective validations, MVP shall outline the parameters and respective rationale for acceptance criteria;[which is obvious]

but most important step is "justifying/resolving" the "gaps/ observations" noted identified during validation. And MVP shall lay down the 'process' and 'criteria' for the same.


Just in case if you have missed these references...
http://apic.cefic.org/pub/Qualification_existing_equipment_final.pdf
Guidance on Qualification of existing facilities, systems,
equipment and utilities

http://www.innovativefacilities.com/Web/Documents/Retro Validation.pdf

btw, could you be a little more specific on the your query..."how much detail..."

2) you mentioned that you have added a new product line of medicated product with a specific claim of effectiveness... the level of details/rigour [mandatory nature and regulatory implications ]also depends on the kind of license you hold for the product. Nevertheless, the claim has to be substantiated suitably through periodic validation process.

hope that helps.
Valiveti

 

[bcoolnow]

I also work for a contract manufacturer of medical devices and am in charge of validations. While I do have templates for the 3 main protocols as well as having a Validation Master List/Plan and have a question regarding such. During a previous customer audit we were issued a CAPA for not having our VML controlled. I have done a lot of research on this on both the FDA and GHTF websites and I do not see anywhere that states that this document is actually required let alone needing to be controlled. I agree it is a good idea to have one but since, during the process of performing validations, this will be updated quite frequently, thus requiring a revision update as well. I call this a living document and therefore it is not controlled, only the form itself would be. Any input on this would be greatly appreciated.