STANDARD OPERATING PROCEDURE DESTRUCTION OF CONTROL SAMPLES OF RAW & FINISHED PRODUCT

STANDARD OPERATING PROCEDURE

SUBJECT :                     DESTRUCTION OF CONTROL SAMPLES OF RAW & FINISHED PRODUCT

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for Destruction of Raw material & Finished Product collected for analysis & Control samples,

2.0       POLICY:

To lay down a procedure for destruction of control samples raw & finished product.

3.0       PROCEDURE:

3.1       Raw Material:

3.1.1    After the completion of analysis and report of the respective Raw material, the material for destruction is identified and reports will be recorded in Annexure-1Sop No.62/QA.

3.1.2    In case of liquids, Raw material is diluted in 10 to 15 liters of water in a bucket, mix well and drain.

3.1.3    In case of solids and powder material mix into slurry with 10 to 15 liters of water and drain.

3. 2      Finished Product:

3.2.1    After the completion of analysis and report of the respective finished product, the material for destruction is identified.

3.2.2    In case of liquids, Creams, Lotion & Ointments the product is diluted in 10 to 15 liters of water in a bucket, mix well and drain.

3.2.3    In case of tablets the product is made into slurry with 10 to 15 liters of water, mixed and then drained.

3.3       Control Samples:

3.3.1    After the completion of the storage period, the product is identified for destruction

3.3.2    The tablets are defoiled. The foil is destroyed by burning the tablets are made into slurry with 10 to 15 liters of water and drained.

3.3.3    In case of Liquids, Ointments, Creams & Lotions the product is diluted with 10 to 15 liters of water and drained.

3.3.4    The closures and containers are defaced cut and discarded.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY:  Executive Q.A.

6.0       REVIEW GUIDE: Destruction record.

7.0       ANNEXURE: 1. Material destruction record format.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x