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