STANDARD OPERATING PROCEDURE MAINTAINING REFERENCE & WORKING STANDARDS OF ACTIVE INGREDIENTS

STANDARD OPERATING PROCEDURE

SUBJECT:                      MAINTAINING REFERENCE  & WORKING STANDARDS OF ACTIVE INGREDIENTS

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

1.0       OBJECTIVE:

To provide guidelines for maintaining the Reference &Working standards of Active Ingredients.

2.0       SCOPE:

To lay down a procedure to maintain reference & working standards of active ingredients.

3.0       PROCEDURE:

3.1       PRIMARY STANDARDS

3.1.1    For the Active ingredient official in Pharmacopoeia, the Primary reference standard would be procured from CDL, Calcutta or from Pharmacopoeia Commission or any other agent dealing with such standards-The standards should accompany the COA.

3.1.2    These Standards will be kept in desiccators or in refrigerator.

3.1.3    This can be used directly without testing.

3.2       WORKING STANDARD

3.2.1    The Active ingredient from regular batch will be taken and dried at suitable temperatures.

3.2.2    The dried samples would be checked against Primary standard.

3.2.3    The Working standard which has been found matching in quality with Primary Standard would be packed in small amber bottles, sealed and preserved in desiccators / fridge  

                 

3.2.4    The Working standard is distributed in 5 small amber glass bottles and are duly labeled with name of standard, B.No., manufacturer date, expiry date, date of preparation, validity date, storage condition, Assay %. Loss on drying or moisture content, bottle no. and prepared by.

3.2.5    The labeling contains bottle No. 1, 2,3,4,5 Bottle Number 1 will be used in the first quarter of the year, and Bottle Number 2 will be used in the second quarter and so on.

3.2.6    At the end of the quarter / year the leftover working standard is destroyed by preparing a solution / slurry in water and then draining.

4.0       FREQUENCY: Annual or Quarterly.

5.0       RESPONSIBILITY: G.M (Q.A).       

6.0       REVIEW GUIDE:  ------

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	x
Warehouse	x	x
General	x	X
Maintenance	x	X