Checklist for BMR Review

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.

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