SOP for Flow of Batch Records

OBJECTIVE

To have a logical flow of batch records so that traceability is easy.

SCOPE

The procedure applies to batch records produced during the production and packing of Products.

RESPONSIBILITY

It is the responsibility of all those involved in the handling of Production Records, Operators, QA Managers, Supervisors, QC/QA Personnel, Warehouse Personnel, Production Manager, Plant Manager, and Accounts Personnel to follow the procedure appropriately.

PROCEDURE

• The Batch documents originate from the QA Manager after the Production Department issues a requisition through the BMR/BPR requisition book.
• The document together with the material requisition is sent to Warehouse.
• Materials are then issued and dispensed with quantities being written and signed for in the Production Document.
• From the dispensing area, the document goes to the production supervisor who shall acknowledge receipt of materials.

• Depending on the product and process the document shall be filled at each stage until the final reconciliation of the bulk and yield calculations.
• The BMR shall be sent to the Production Clerk who shall record the yields and times taken to complete the activity.

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• The document shall be sent to Production Manager for review and checking.
• The Production Clerk will send the completed document to QC for review.
• The BPR also goes through the same procedure till it unites with the BMR.
• The QC Department shall attach the analysis report and send a document to QA Manager for review.
• After review, the QA Manager will send the combined document back to the Production Clerk for final reconciliation.
• The reconciliation document and the Batch records will be finally reviewed and verified by the Plant Manager.

• The reconciliation document will go to Accounts for costing while the BMR and BPR go to QA for retention.
• Each individual will sign in the logbook after receiving a batch record to enable traceability of the document. The date and time they received the document, the date and time they are through with it to whom they have passed it to.
• Individuals should exercise care while handling documents and should be found at the stage of the process and to be locked up if not in use to avoid loss.

ABBREVIATION

BMR: Batch Manufacturing Record

BPR: Batch Packing Record

QC: Quality Control

QA: Quality Assurance

ANNEXURE

Nil

REVIEW HISTORY

Nil

ALSO READ: SOP for Receipt of COA from QC