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BPR is Batch Packing Record.
Review includes checking all parameters & process mentioned in BPR.
Dispensing activity includes checking of all packing material required for pzcking.
A. R. No., Batch no., Release status, Qty. Available & Required also
Batch packaging record include packaging method and thier instruction including quantitative details of packaging and semifinish product for c GMP documentation with relevant all process parameter, online observation, reconsilation in formats/annexure/template of pre- approved formats(BPR).
Review in any stage of packaging i.e. during mastering of batch packaging record, during online packaging process parameter review, stage to stage clearance also part of review, least but important before dispatching review.
Dispensing process includes environment parameter, RALF/LAF , weighting machine, manpower, calibration detail of all Dispensing area, dispense material detail’s in dispensing sheet,log card, dispense lable etc.
Also While BPR review need to check the
- Proof of packaging materials used, while execution and during final review.
- Extra material consumption & return…
- Equipment and area logbook usage time with BPR time…
BPR is batch packaging Record.
Review of BPR is done By packaging Supervisor then Packaging Pharmacist before handling over to QA to release finished product batch.
In review full BPR is thoroughly checked for following
All activities performed are mentioned.
All linrclearnce sheets properly filled and attached
Machines Deployment sheets
Personnel Deployment Sheets
Printed carton attach.
Blister and foil samples attached.
Packaging parameters sheets properly filled n signed
Transfer notes from Packaging hall to quarantine attach
No sign missing.
Cross n signed all blank pages.