Checklist for Batch Review in Liquid Manufacturing
Checklist for Batch Review in Liquid Manufacturing
| Section | Audit Point | Compliance (Y/N) | Remarks |
|---|---|---|---|
| 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 | Dispensing is carried out on a calibrated balance | ||
| Raw Material Requisition is available | |||
| Line clearance is taken prior to all dispensing and manufacturing activities | |||
| Dispensing is carried out as per work order | |||
| Raw Materials | Raw Material Assessment Sheet is available | ||
| All dispensing labels are properly affixed | |||
| Environment | Environmental conditions comply during all manufacturing steps | ||
| Documentation | No overwriting is observed; wrong entries are struck out and signed | ||
| Equipment | Actual equipment used is as specified | ||
| Purified Water is released from QC | |||
| Manufacturing | Pre-sifting and sifting checks are performed and recorded | ||
| Wt./ml and pH of sugar syrup (if applicable) are checked and recorded | |||
| Mixing time is as specified and recorded | |||
| Temperature during the addition of colors and flavors is as specified and recorded | |||
| Final filtration and volume makeup are recorded | |||
| Final pH and wt./ml are recorded | |||
| QC approval for bulk is available on the technical information sheet; release label is affixed | |||
| Reconciliation | Yield reconciliation of bulk is within the acceptable limit | ||
| In-Process | All in-process check results comply with acceptance limits | ||
| Deviations | Any deviations during the process are raised and approved | ||
| Deviations, incidents, or change control related to the batch are attached to the batch record | |||
| Deviations, incidents, or change control are closed before releasing the batch | |||
| Packing | 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 | |||
| In-Process Checks | In-process checks during washing of bottles are performed at defined frequency | ||
| In-process checks during filling/sealing of bottles are performed at defined frequency | |||
| In-process checks during packing are performed at defined frequency | |||
| Compliance | All in-process check results comply with acceptance limits | ||
| Documentation | Approved specimens of 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 | Material reconciliation is performed and correct | ||
| Yield reconciliation of finished goods is within the acceptable limit | |||
| Deviations | Any deviations during the process are raised and approved | ||
| Deviations, incidents, or change control related to the batch are attached to the batch record | |||
| Deviations, incidents, or change control are closed before releasing the batch |
This checklist ensures all aspects of the manufacturing and packing process are reviewed and comply with standards.
Zulkifal
0
Tags :