STANDARD OPERATING PROCEDURE TESTING AND RELEASE OF RAW MATERIAL



STANDARD OPERATING PROCEDURE

SUBJECT:                     
TESTING AND RELEASE OF
RAW MATERIAL

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

1.0       OBJECTIVE:
     
To provide guidelines for release of raw material and Packing material

2.0       SCOPE:  

To approve of raw materials for Manufacturing after testing.

3.0       PROCEDURE:

3.1       The Executive QA / Jr. Executive responsible for the sampling is witnessed by another QA
            Executive the sampled raw materials are tested as per the laid down specification.

3.2       After analysis, results and observations will be recorded in the observation book.

3.3.      If the material is passed as per the specification APPROVED sticker will be pasted on the containers in the designated place and the consignment will be shifted from quarantine area to approved material area and will be stored lot wise.

3.4.      A certificate of analysis in the RM report format will be prepared for DRL and at the time of
            release duly signed by the G.M (Q.A).

3.5.      If the material is found failing as per specification, REJECTED stickers will be pasted on the containers and the consignment will be shifted from quarantine area to rejected material area.  A certificate of analysis is prepared for the rejected material

3.6.      The G.M Q.A will send back GI after filling the details & sign along with the COA to
            warehouse for their record.

3.7.      Warehouse Executive will inform purchase department about the rejection. The rejected material will be returned to manufacturer.

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY: General Manager Quality Assurance/ QA Executiv

6.0       REVIEW GUIDE: Raw material entry register and RM results register.

7.0        ANNEXURE:  1. Schedule ‘U’III (D) Raw Material Analytical Report.
2. Status labels.
3.DRL report format for raw materials.

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
General
x
x
Maintenance
x
x

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