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The Batch Production Record (BPR) Review Procedure and Checklist is an essential standard operating procedure (SOP) designed to ensure the accuracy and compliance of batch manufacturing and packing records. This comprehensive document outlines the systematic approach for reviewing BPRs, facilitating the identification of discrepancies and ensuring adherence to regulatory requirements. The checklist serves as a practical tool for quality assurance teams, promoting consistency and thoroughness in the review process, and ultimately enhancing product quality and safety.

Batch Production Record Review Procedure

1.0   Objective

• • To lay down a procedure for receiving and reviewing of Batch Production Record and release of bulk / intermediate products for packing and packed finished products for dispatch to the markets.

2.0   Scope

• • This SOP is applicable to all formulation manufactured at pharmaceutical drug manufacturing plant.

3.0   Responsibility

4.0   Procedure for Batch Production Record (BPR) Review

• • Review of Batch Manufacturing Record (BMR):

• • After completion of manufacturing the Production Chemist shall check the following:

• • • BMR is completely filled and all the pages of BMR are arranged.

• • • Reconciliation is done and sample quantity of bulk / semi-finished samples has considered in reconciliation.

• • • All the relevant enclosure are properly filed and signed.

• • • Entry of batch in machine logs.

• • • Corrections are signed and dated with remarks.

• • After ensuring above Production Chemist shall hand over the Batch Manufacturing Records to Officer/Executive Production for review for any deficiency.

• • Officer/Executive Production shall review the Batch Manufacturing Records as per Annexure-II for Tablets/Capsules and Annexure-III for Oral Liquids.

• • After review Officer/Executive Production shall submit the Batch Manufacturing Record to QA chemist for any deficiency, correct reconciliation etc.

• • QA Chemist shall review the BMR for –

• • Complete entries,

• • Missing of any report,

• • Reconciliation,

• • Destruction record,

• • Any Deviation,

• • Change Control,

• • Failure Investigation,

• • CAPA,

• • OOS and missing entries/signatures shall be recorded in the Batch production record Review Sheet, Annexure-II for Tablets/Capsules, and Annexure-III for Oral Liquids.

• • If any observations/deficiencies are made, they will be discussed with the Production Chemist and Production Head, and action will be taken.

• Officer/Executive QA shall review BMR as per the checklist attached in BMR, Annexure-II for Tablets / Capsules and Annexure-III for Oral Liquids and approve the same, in case of any deficiency found same shall be corrected immediately by Production and /or QA or jointly.

• Release for Compression / Filling:

• • The production chemist shall raise the Intimation of Bulk Products” i.e. Bulk Powder or Oral Liquids in duplicate to the QA chemist after the Bulk stage.

• • QA chemist shall accept the Intimation of Bulk Products from the Production chemist only if the Batch Manufacturing Record (BMR) is complete.

• • The chemist of the QA department shall withdraw the sample as per the respective SOP and sign the “Intimation of Bulk Products” along with the sample quantity. Then, the entry shall be done in BMR with the signature.

• • QA chemist shall send the “Intimation of Bulk Products” along with the sample to Quality Control for analysis and file the second copy in BMR.

• • After analysis, the QC chemist shall hand over the bulk release report with comments to the QA chemist. QA chemist shall review the comments and if the bulk:

• • • If released, QA chemist shall file the report in BMR and put comments on the Status Label of Bulk Products along with the signature.

• • • If not released, the QA chemist shall file the report in BMR and affix the duly filled and signed “Hold Label” on the Status Label of Bulk Products. Out-of-specification results shall be handled as per SOP.

• • After completion of manufacturing activity production chemist shall file the Status Label of Bulk Products in BMR.

• Release for Coating stage:

• • The production chemist shall raise the Intimation of Semi-finished Products” i.e. Uncoated tablets in duplicate to the QA chemist at Completion of Compression.

• • QA chemist shall accept the Intimation of Semi-finished Products from the Production chemist only if the Batch Manufacturing Record (BMR) is completed.

• • The chemist of the QA department shall withdraw the sample as per the respective SOP, sign the “Intimation of Semi-finished Products” along with the sample quantity, and also make an entry in BMR with the signature.

• • QA chemist shall send the “Intimation of Semi-finished Products” along with the sample to Quality Control for analysis and file the second copy in BMR.

• • After analysis, the QC chemist shall hand over the Analytical Report with comments to the QA chemist. QA chemist shall review the comments and if the uncoated tablets:

• • • If released, the QA chemist shall file the report in BMR and put comments on the Status Label of Intermediate Products along with the signature on each container.

• • • If not released, the QA chemist shall file the report in BMR and affix the duly filled and signed “Hold Label” on the Status Label of Intermediate Products on each container. Out-of-specification results shall be handled as per SOP.

• Release for Packing stage:

  • The production chemist shall raise the Intimation of Semi-finished Products” i.e. Uncoated tablets / coated tablets / filled capsules in duplicate to QA chemist at Completion of stage.

• • QA chemist shall accept the Intimation of Semi-finished Products from Production chemist only if the Batch Manufacturing Record (BMR) is complete.

• • The chemist of the QA department shall collect the sample as per the respective SOP and sign the “Intimation of Semi-finished Products” along with the sample quantity and also make entry in BMR with the signature.

• • QA chemist shall send the “Intimation of Semi-finished Products” along with sample to Quality Control for analysis and file the second copy in BMR.

• • After analysis QC chemist shall handover the Analytical Report with comments to QA chemist. QA chemist shall review the comments and if the uncoated tablets/ coated tablets / filled capsules:

• • • If released, QA chemist shall file the report in BMR and put comments on Status Label of Intermediate Products along with signature.

• • • If not released, QA chemist shall file the report in BMR and affix the duly filled and signed “Hold Label” on Status Label of Intermediate Products on each container. Out-of-specification results shall be handled as per the respective SOP.

• • After completion of packing activity production chemist shall file the Status Label of Intermediate Products in BMR.

• • During packing of a batch, QA Chemist shall collect Control Samples, Stability Samples (if applicable), Registration Samples (if any) and other Samples and records in the BPR.

• • Intermittent verification of packed shippers shall be done by QA chemist for correct quantity, legibility in overprinting etc. during packaging activity.

• • QA chemist shall recheck batch document for compliance of deficiencies.

• • QC shall submit two copies of COA (Approved or Rejected) to QA along with a signed copy of FPRR which shall be part of BPR.

• • Head-QA/Designee shall review the BPR as per the checklist given in Annexure-II for Tablets/Capsules and Annexure-III for Oral Liquids, in case any deficiency corrective action taken immediately by Production and/or QA or jointly.

• • In case the batch is rejected by QC then Failure Investigation shall be initiated and disposal is done according to CAPA finalized in the investigation.

• Review of Batch Packing Record:

  • After completion of the batch, BPR shall be reviewed and signed by Production Head.

• • Production Chemist shall submit the completed BPR to QA Chemist along with Finished Product Transport Note.

• • QA Chemist shall ensure the completion of BPR and check the following as per Annexure-II for Tablets/Capsules and Annexure-III for Oral Liquids.

• • • Batch record is completely filled and all the pages of BPR are in-place.

• • • All the relevant enclosure and properly filed and signed.

• • • All the reconciliations are done.

• • • Check relevant equipment / machine log for data entry.

• • • Wherever required signed samples of printed packing materials are enclosed.

• • • Corrections are signed and dated with remarks.

• • • The packed quantity is entered into the system through the Finished Product Transfer Note and the printout is enclosed in the batch production record in duplicate.

• • • Wherever required signature of Production chemist and Head Production or Designee is there.

• • • Ensure that the report is consistent with the specification of product.

• • • Any Deviation, Change Control, Failure Investigation, CAPA if any are properly addressed and the actions are planned.

• • • Ensure that the QC Sample, stability / control samples or other sample are collected as applicable.

• • QA shall select the C-box on random basis as per respective SOP for  “Terminal Inspection”, open the C-box and check carton / Label / Inner Box, strip/blister/ bottle, and check for Product Name, Mfg. Lic. No., Batch No., Mfg. date, Exp. Date, MRP as mentioned in BPR and 2 D bar coding whereas applicable.

• • QA shall cross verify the packing details on C-box and also check the loose C-box for quantity.

• • QA shall cross verify the tertiary bar coding details on C-box.

• • After review QA Chemist shall sign the Batch Production Record Review Sheet and hand over to Head QA/ Designee for review

• • Ensure that the sample of each brand is sent to QC, if a batch is packed in more than one brand or supplied to various institutions with specific overprinting details.

• Checking of Finished Goods Transfer Note:

• • • Product Group i.e. Liquid / Tablets / Capsules.

• • • Finished Product Transfer Note Number & Date.

• • • Product Name, Batch No., Batch Size, Mfg. Date & Expiry Date.

• • • Packing Type i.e. 10’T/15’T/14’T/4’T/2’T/1’T etc. for tablets as applicable, 10’C/15’C/2’C/7’C etc. for capsules as applicable, 30ml/50ml/60ml/100ml/150ml/200ml etc. for Oral Liquids as applicable.

• • • Supply for Sale, P.S., Export, Hospital supply & Government Supply etc.

• • • Quantity Transferred.

• • • Pack Size (per carton/catch box/shipper & volume in case of bottle)

• • • Check the entry in BPR.

• • • Full transfer / part transfer

• • QA chemist shall record any deviation/deficiency (if any) in the Annexure III & IV and return the BPR to Production Chemist for correction.

• • Head QA / Authorized Person for batch release shall release the batch in the system as per respective SOP for “Release of Finished Products for Sale and Distribution”.

• • After release of Finished Product submit the BMR to QA office and final signature and storage.

• • Any documents which are issued additionally same shall be enclosed in the BMR/BPR and recording shall be done as per Annexure-II & Annexure-III.

Annexure-I: Batch review/ release/ rejection flow sheet

Annexure-II: Batch Production Record Review Sheet (Tablets/ Capsules)

Product Name           : ……………………………………………                  B. No.: ………………………..

Mfg. date                      : ……………………………………………               Exp. Date: ……………..

Annexure-III: Batch Production Record Review Sheet (Oral Liquids)

Product Name           : ……………………………………………                  B. No.: ………………………..

Mfg. date                    : ……………………………………………                  Exp. Date : ……………..