Checklist for Batch Review in Liquid Manufacturing : Pharmaguideline

Manufacturing

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.

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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