Checklist for Batch Manufacturing Record (BMR) Review
Checklist for Batch Manufacturing Record (BMR) Review
| Audit Area | Checklist Item | Compliant (Yes/No) | Remarks |
|---|---|---|---|
| BMR and Label Issuance | Issuance of BMR and label claim is proper. | ||
| All pages are available and comply with the index. | |||
| Manufacturing and expiry dates are correctly allotted. | |||
| Dispensing Activities | Dispensing is carried out on a 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. | |||
| All dispensing labels are properly affixed. | |||
| Environmental Compliance | Environmental conditions comply during all manufacturing steps. | ||
| Documentation Accuracy | No overwriting is observed, and all wrong entries are struck out and signed. | ||
| Equipment Usage | Actual equipment used is as specified. | ||
| Manufacturing Steps | Pre-sifting checks, sifting, and pre-mixing checks are performed and recorded. | ||
| Mixing and preparation of binding agents are proper. | |||
| Granulation pre-drying checks are performed and recorded. | |||
| Size reduction, final drying, and inclusion of residue are done correctly. | |||
| Lubrication and pre-compression checks are performed and recorded. | |||
| Yield reconciliation of the blend is within the acceptable limit. | |||
| QC Approvals | QC approval for bulk is available on the technical information sheet, and the release label is affixed. | ||
| QC approval for compressed tablets or filled capsules is available on the technical information sheet. | |||
| QC approval for coated tablets is available on the technical information sheet. | |||
| In-Process Checks | In-process checks are performed at a defined frequency and comply with specifications during compression or filling. | ||
| All in-process check results comply with the acceptance limits. | |||
| Coating Steps | Preparation of coating solution and coating are performed as per the defined procedure. | ||
| Yield reconciliation of coated tablets is within the acceptable limit. | |||
| Deviations and Incidents | Any deviation during the process is raised and approved. | ||
| If deviations, incidents, or change controls are raised, they are attached to the batch record. | |||
| Deviation, incident, or change control is closed before batch release. | |||
| Packing Activities | Issuance of BPR and label claim is proper. | ||
| All pages are available and comply with the index. | |||
| Manufacturing and expiry dates are correctly allotted. | |||
| Packing Material Requisition is available. | |||
| Dispensing is carried out as per requisition. | |||
| Line clearance is taken prior to all packing activities. | |||
| Documentation Accuracy | No overwriting is observed, and all wrong entries are struck out and signed. | ||
| In-Process Checks | In-process checks are performed at a defined frequency and comply with the acceptance limits. | ||
| Packing Specimens | Approved specimens of foil, cartons, labels, or shipper stenciling are affixed. | ||
| Packing Documentation | 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. | |||
| Deviations and Incidents | Any deviation during the process is raised and approved. | ||
| If deviations, incidents, or change controls are raised, they are attached to the batch record. | |||
| Deviation, incident, or change control is closed before the release of the batch. |
This checklist ensures a thorough audit process covering all critical aspects of manufacturing and packing in the pharmaceutical industry. Let me know if you’d like to add or refine specific sections!
Zulkifal
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