Checklist to review the batch manufacturing record and batch packing record of pharmaceutical products manufactured in pharmaceutical facility.
Manufacturing:
Issuance of BMR and Label claim is proper.
All the pages are available and comply with the index.
Manufacturing and expiry are correctly alloted.
Dispensing is carried out on calibrated balance.
Raw Material Requisition is available.
Coating Material Requisition is available.
Line clearance is taken prior to all dispensing and manufacturing activities.
Dispensing is carried out as per work order.
Raw Material Assessment Sheet is available.
All dispensing labels are properly affixed.
Environmental conditions comply during all the manufacturing steps.
No overwriting are observed and all wrong entries have been a strikeout and signed.
Actual equipment used is as specified.
Pre sifting check, sifting & pre mixing checks are performed and recorded.
Mixing & Preparation of Binding Agents is proper.
Granulation Pre drying checks are performed and recorded.
Size Reduction, Final Drying & inclusion of Residue.
Lubrication & Pre Compression Checks are performed and recorded.
Yield reconciliation of blend is within the acceptable limit.
QC approval for bulk is available on technical information sheet and release label is affixed.
In- Process checks are performed at a defined frequency and are as per Specification during Compression or capsule filling.
QC approval for compressed tablets or filled capsules is available on technical information sheet and release label is affixed.
Yield reconciliation of compressed tablets or filled capsules is within the acceptable limit.
Preparation of coating solution and coating is performed as per the defined procedure.
Yield reconciliation of coated tablets is within the acceptable limit.
QC approval for coated tablets is available on technical information sheet and release label is affixed.
All the in-process checks results comply with the acceptance limit.
Is there any deviation during the process and deviation is raised and approved.
If any deviation, incident, change control raised related to the batch attached with the batch record.
Deviation, incident, change control is closed before the release of the batch.
Packing:
Issuance of BPR and Label claim is proper.
All the pages are available and comply with the index.
Manufacturing and expiry are correctly alloted.
Packing Material requisition is available.
Dispensing is carried out as per Requisition.
Line clearance is taken prior to all packing activities.
No overwriting are observed and all wrong entries have been a strikeout and signed.
In- Process checks are performed at a defined frequency.
All the in-process checks results comply with the acceptance limit.
Approved specimens of foil, cartons, labels or shipper stenciling are affixed.
Finished Good Transfer Note is affixed.
Packing Material Return Note is affixed.
Finished Product Release Slip is affixed.
Extra Material Requisition is affixed.
F.P. report/ In process Report is affixed.
Reconciliation of material is performed and is correct.
Yield reconciliation of finished goods is within the acceptable limit.
Is there any deviation during the process and deviation is raised and approved.
If any deviation, incident, change control raised related to the batch attached with the batch record.
Deviation, incident, change control is closed before releasing of the batch.
