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 .
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