Checklist for BMR Review : Pharmaceutical Guidelines

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Checklist for BMR Review

Checklist to review the batch manufacturing record and batch packing record of pharmaceutical products manufactured in pharmaceutical facility.

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 T.I. 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 T.I. 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 T.I. 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.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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