Reg Trial Batch during new product introduction

Dear Mr. Ankur

During introduction of new product (API) from R&D, is it acceptable to revise acceptance criteria of certain test parameters of intermediates (non-conformance) during trial batch (before creating validation protocol)?

Similarly cases like starting materials/raw materials of new product analyzed for trial batch and found to be non-conforming. Is it acceptable to evaluate and revise spec to accommodate the material.

What is the regulatory (quality assurance) evaluation of such cases against commercialized product. Is it justifiable? since it is a new molecule and changes (in spec/operation) were done only during trial batch.


Hi Srimurugan

During the analytical development we developed the specification, after tech transfer from ADL to Commercial, if it is observed the different then we change the specs or method by justifying technically with ADL through change control

Yes, with proper justification u can change

yes, we change the test parameters of intermediates during trial batch manufacturing. But with justification and quality risk assessment of product. And same batches quality attributes evaluated.

Dear All,
What is the strategy for cleaning validation of equipment used for manufacturing of development product during development phase and regular small scale commercial products