STANDARD OPERATING PROCEDURE REPROCESSING OF FINISHED PRODUCT

STANDARD OPERATING PROCEDURE

SUBJECT:                      REPROCESSING OF FINISHED PRODUCT

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

1.0       OBJECTIVE:

To provide guidelines for the reprocessing of the finished product.

2.0       POLICY:

Applicable to get finished product with all qualified Specifications.

3.0       PROCEDURE:

3.1          The Quality Assurance dept. will submit an Analytical report with respect to the rejected product.

3.2       Q.A will inform the production dept. and also the Parent company. The product will be kept under hold.

3.3       The product container is labeled as “UNDER HOLD” specifying the following;

Name of the Product:                           Batch size:

Batch no:                                             Exp dt      :                                          

Manufacturing date:

3.4          The production dept. and the Parent company will evaluate the possibility of             reprocessing the product based on the nature of the problem.

3.5       Reprocessed product should meet the following criteria.

The reprocessed product meets the specifications in all respects.

The product stability should not be affected.

3.6       All reprocessing work will be carried out under the supervision of Parent company representative and production dept. of Elegant.

3.7       Reprocessed batch should be analyzed as per the laid down specifications, if it confirms to specifications the batch should be released.

 

3.8       A record should be kept giving the following details;

Name of the product

Batch Number

Place of Manufacturing

Date of Manufacturing

Type of Reprocessing

Date of Reprocessing

3.9       Incase of Liquids, Ointment, and Creams & Lotions reprocess is not done.

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY: Parent company & Elegant.

6.0       REVIEW GUIDE: Batch manufacturing record.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

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