For product Quinine Dihydrochloride we already prepared BPCR, flow chart, testing protocol, spec all related documents.
But we want to prepare it from different route (from different intermediate - one step additional) then, is it possible that Quinine Dihydrochloride have two different route process BPCR ??? (2 different process route for the same product)??
Plz sir reply me with satisfactory explanation. I’m awaiting for your favourable reply…thanks sir…
@qa.12345
If ROS (route of synthesis) is different then it is considered as different process. for this you have to undergo all the validation with separate documents (BPCR, product code, notification to customer or regulatory department(s), DMF etc) including registration of product with new ROS. In Short its a new product for you.
Sir for this type product, I have to give different product code & batch no. (serial no) also different than exist code and continuous serial no.???
e.g. we going to prepare one step process (one intermediate) from different route than the exist one. We also want to keep both process route permanently or documented.
Then particularly for this intermediate - product code, batch serial no, MFR, spec, MOA, Analytical report etc…all this things have to be prepare distinctly from exist one…Spec & MOA documentary will be same ?? All the Tests are same for both processed product.
What I Have To Do ??? Sir plz guide…
You can prepare two different batch records etc.
If the product is for regulatory market then you have to opt Regulatory approval and needs to inform your customers before supply.
Then particularly for this intermediate - > product code, batch serial no, MFR, spec, MOA, Analytical report etc…all this things have to be prepare distinctly from exist one ???
Spec & MOA documentary will be same ?? All the Tests are same for both processed product.