Can manufacturer harmonised the specification as per the IP, EP & USP monograph and will it be acceptable to Regulatory agencies ?
The API manufacturer can harmonize the common specification as per IP, BP, and USP. However, the API manufacturer must have a license to manufacture the same API material with different pharmacopoeial grades.
It is advisable to submit only a single specification (including in-house tests) for DMF of that API to the regulatory authority of that country (Like USP specification for USFDA submission, IP specification for CDSCO, EP specification for EU countries submissions (EMA), and BP specification for MHRA-UK submission.
Thank you so much Sir for the elaborated clarification.
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