Checklist for Batch Review in Liquid Manufacturing

Manufacturing

• Issuance of BMR and Label claim is proper.
• All the pages are available and comply with index.
• Manufacturing and expiry are correctly alloted.
• Dispensing is carried out on 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 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 strikeout and signed.
• Actual equipment used is as specified.
• Purified Water is released from QC.
• 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.
• The temperature during the addition of colors and flavors is as specified and recorded.
• Final filtration and volume make up records
• Final pH and wt./ml is recorded.
• QC approval for bulk is available on technical information sheet and release label is affixed.
• Yield reconciliation of bulk is within the acceptable limit.
• 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 manufacturing record.
• Deviation, incident, change control is closed before releasing the batch.

Packing

• Issuance of BPR and Label claim is proper.
• All the pages are available and comply with 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 strike out and signed.
• In-process checks during Washing of bottles are performed at a defined frequency.
• In-process checks during filling/sealing of bottles are performed at a defined frequency.
• In-process checks during Packing are performed at a defined frequency.
• All the in-process checks results comply with the acceptance limit.
• 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 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 manufacturing record.
• Deviation, incident, change control is closed before releasing the batch.

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