Retrospective Validation - Producing Product Over 10 Years

[donnapie]

Hello-I work for a contract manufacture that produces body powders. The powder that is in question is a medicted body powder. My question is can I use retrospective validation if I have test data for all lots produced and stability data. There has been no change to the process in 8 years.

I do APR on the product in question and last year there were no non-conformances of the said product. Which would be easier do a validation from "scratch" as if the product was just put on the market or use retrospective validation?

We have no validations that have been completed since 2003. We have been audited by the FDA and haven't been issued any 483's. We have had recent 3rd party audits that state the need for Process & Equipment validations and a formal Equipment IQ/OQ/PQ program. I am just trying to find the best way to put these plans in place in a system that has been in place many years and has had no changes to the process in almost 10 years. Any help would be greatly appreciated.

 

[MIREGMGR]

Re: Retrospective Validation Producing Product Over 10 Years

Which would be easier do a validation from "scratch" as if the product was just put on the market or use retrospective validation?

I'd think you'd want to do a combination of both. It appears from your brief information that legally you either have to establish regulatory legitimacy for your past-shipped product, or start talking to your customer(s) about recalling it. Comprehensive validation on a forward-going basis would put you in a much more comfortable position at some point in the future during either a competently performed FDA inspection or a customer audit, given that you'll likely have to discuss this gap in your company's regulatory performance.

 

[donnapie]

Re: Retrospective Validation Producing Product Over 10 Years

There is finished goods testing done on all batches and there are also stability studies done so why the recall comment?

 

[MIREGMGR]

Re: Retrospective Validation Producing Product Over 10 Years

Either you're required to validate, or you aren't.

If you're required to validate, and you haven't, your production has been noncompliant.

If on the other hand you're not required to validate because you've verified every relevant parameter...what is the point of your concern about validation?

 

[donnapie]

Re: Retrospective Validation Producing Product Over 10 Years

Hello-My concern about validation comes from a recent 3rd party audit. They are requiring validation. I was under the assumption that we were covered because every single batch is tested before release. If we are required to validate I want to be compliant but just not sure how to go about doing it. Thanks

 

[MIREGMGR]

What will the validation establish that the verification does not? Did the third party identify an aspect of the product that the verification does not or cannot control?

In regard to your prior production and retrospective validation, have you always verified to the extent you do now, or would the retrospective validation be intended to improve the compliance stance of past batches?

 

[donnapie]

They said that my Quality System does not establish the need for process & equipment validations. They also said that there is not a master validation plan in place. There is no formal program for equipment IQ/OQ/PQ. Yes we have always had every single batch tested on finished product. They are tested for the active and micro. That is why I am confused when they are requesting validations, isn't testing and documenting every finished batch a form of validating my process? Or do I need to go throught the whole IQ/OP/PQ?

 

[Juan Dude]

Validation can be a risky word play and without knowing your process or your product I hesitate to give concrete advice to you so I suggest that your regulatory or QA function to do research on the FDA’s validation requirements so that way you will see that although your 3rd party auditor is technically correct in your particular case that does not necessarily mean you have to validate, retrospective and even no validation may be perfectly fine in your case considering that you are doing 100% inspection but you do have to put this in writing in a validation SOP and proceed accordingly.