Process validation

GOOD VALIDATION PRACTICE (cGVP)
1

Dear Friends,

Some of the products are transferred within sites (ie.,from site 1 to site 2 ) permanently. In that case we perform concurrent validation for the transferred products. Suppose if the product is filed for any regulated markets, generally exhibit validation batch reports should be submitted.
My doubt is, the exhibit validation batch reports will be as per site 1 (w.r.t environmental control, mfg process, equipment operation…) but when the product is transferred to site 2 i believe some changes will be there (w.r.t environmental control,mfg process , equipment operation).

a) In what way this transfer from site 1 to site 2 affect the product quality.

b) Stability status of the product, when the product is cross referred to exhibit valildation batch .

c) If so is it sufficient to submit only the concurrent validation report to the regulated market of site 2 .
or
d) We have to submit the exhibit validation batch report of site 1 & concurrent validation report of site 2 .

Can any one suggest, how can we justify this change in validation

Thanks

sowmya

2

With respect to question a:
We can not answer that question. That is what you have to to. Investigate all changes (in conditions, in utilities, in mfg processes, etc) and the impact they might have on final product. It is a kind of risk assessment. For all high risk changes you have to perform validation. If you can justify the change has no impact you do not need to validate (e.g. based on the validation data utilities at both sites can be considered identical, therefore they do not have impact on final product). Where you do not perform a new validation, you leverage the old validation data. Final confirmation if you have performed the risk assessment properly is to conduct the product performance qualification. If you manufacture product at the new site does it meet specification similarly as at the old site?

What you need to submit to regulatory authorities highly depents on the type of product, the country, etc. Please consult your regulatory authority to discuss what they expect.