Batch Release For Sale SOP


Batch Release For Sale SOP

1.0   PURPOSE:

1.1. To ensure compliance of Product Release requirements before dispatch to the market.

2.0    SCOPE:


2.1  This procedure applies to all the products manufactured within premises of _____________ Pharmaceuticals

3.0   RESPONSIBILITY:


3.1.      Inventory Control manager
3.2.      Quality Assurance Manager
3.3.      QA Officer
3.4.      Store Worker


4.0    PROCEDURE:


4.1.      After receiving finished goods from production department, the Officer Inventory Control sends intimation to the Quality Assurance Department for final inspection before dispatch.
4.2.      QA Officer documents the respective batch details in Log Book of product release certificate for sale.
4.3.      QA Manager reviews the batch manufacturing record (BMR 05-003) and ensures its completion in all aspects before final release.
4.4.      QA Officer randomly inspects the product packs of received batch; specially the loose master shipper (if any) and documents the observation on Product Release for sale Certificate (F-07-005).
4.5.      Q.A Manager will review, sign. and authorizes batch release on Product Release for sale Certificate (F-07-005)
4.6.      Q.A. Officer affixes the Green colored Release stamp from QAD on each and every master carton of the batch ready for dispatch.
4.7.      After Final release QA Officer takes the batch manufacturing record (BMR) in QA Custody and keeps it safe and sound in Record Room.
5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.




Evidence of Records and References
PRB-07-005
F-07-005 (Product Release Certificate)
Formal KPI (Key performance Indicator)
No batch should be dispatched without Release Certificate and completion of BMR.
GENERAL RISKS
C O N T R O L      M E A S U R E S
CUSTODIAN
RISK
IMPACT
Dispatch of unreleased batch to the market
Problematic product may deliver to Market, resulting in high risk for patients’ health
Batch must be released before its dispatch to the market



QA Officer / Store Incharge
Release Stamps has not been affixed after batch release
Mixing of released and unreleased products in FGS (finished goods store)
Affix the stamps as soon as the batch is released for dispatch


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