SOP for Batch Release System

Objective

To describe the procedure for the Release / Rejection of drug products that are intended for dispatch.

Scope

This procedure is applicable to the entire finished product manufactured at XYZ Ltd.

Responsibility

Analysis of finished goods : Executive / Officer- QC.

Review of analysis and batch manufacturing record : Executive / Officer-QA

Release / Reject of the Batch : Head-Quality / Manager-QA

Accountability

The Head-quality shall be accountable for the compliance of the system.

Procedure

• Following procedure to be followed for Batch Release:
• Batch Manufacturing Records Review and Analytical document Review shall be carried.
• All the product records, including those for packing and labeling and analytical records shall be reviewed to determine compliance with the approved procedures.

• Any discrepancy or failure of batch or any of its components to meet any of its specifications shall be investigated.
• The data recorded in batch records shall be signed and certified by the responsible supervisor.
• It shall be ensured that appropriate retain samples of the final product have been retained as per SOP for handling of Control / Retention Samples.

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• When Batch Records (Production, Packing & Analytical Records) are found satisfactory after review, the batch shall be released by Head-Quality / Designee.
• The release shall be conveyed to Production In-charge / Warehouse in charge through “Batch Release Note”. The batch Release Note shall be attached with the completed batch manufacturing record.
• In case of rejection, the "Rejected" stickers shall be affixed to every container or drum holding the rejected material.

Abbreviations

SOP : Standard Operating Procedure

QA : Quality Assurance

NA : Not Applicable

Annexure

Annexure-1: Batch release note

Revision History

Nil

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