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SOP for Batch Release System

Objective
To describe the procedure for 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 the 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.
  • 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”. Batch Release Note shall be attached with 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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