Commitment letter for Process Validation

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi everybody,

We are making the process validation for the production of an API. Our custumer is aksing us for a “Process Validation commitment letter for the first three batches of post-marketing commercial production”.

Does everyone know what it is? Is there an “official” template for that kind of document?

Thank you for your help!

Claire

2

Process validation commitment letter is required, when you didn’t include three production scale batches in the process validation. In that case we need to give a commitment saying that the first three commercial batches will be validated and the data shall be submitted to the Regulatory authority.

regards,

Rama