On What basis Batch Manufacturing Record Shall be prepared:question:
Based on process development Report
Line clearance checks
Step wise processes
all controlled parameters n checks
product yield etc
Should be prepared based on registration document and dossier
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.