Preparation of BMR

On What basis Batch Manufacturing Record Shall be prepared:question:

Based on process development Report

on following.
Line clearance checks
Machines used
personnel involved
used formulation
Step wise processes
all controlled parameters n checks
product yield etc

tq sir

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dr.reddys kada

Should be prepared based on registration document and dossier

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didn’t get ur point sir

MFR , dossier , data from scale-up batches, SOP parameters, Procedure developed by R&D department, With the TT team.


Which is we are using to get our indented project, it’s having complete information about raw materials converting into final product. Everything covered in BMR, it is a final report taken from process R & D, developed by tech transfer, and finally QA will review and give approval to proceed further with inprocess check points, for better process.