Claim of the finished prodct

Regulatory
1

My question is:

  1. If drug substance is pharmacopoeial, say for eg. the API supplier provides the API as per EP specification, but the finished product supplier tests the API using USP specification, what will be the label claim of the final finished product.

Under what circumstances is it possible to EP to USP or vice versa analysis? is it allowed, what are the requirements to be met it we need to do so.

  1. If the drug product manufacturer uses different pharmacopeial tests to analyze the finished product, what should we claim the finished product as?
2

Hai,

  1. The material analysed as per usp pharmacopeia if it meets all the parameters can use it for USP grade

  2. The finished product manufacturer doing analysis of different pharmacopeial tests he will address the reference of that pharmacopeia and perform method verifications. After that is ok, he will prepare the specification as in-house from the reference of pharmacopeial tests.