SOP For Preparation of Primary Standard

1.0                       Objective:

               To provide written procedure for usage of primary working standard.     

2.0                       Scope:

               This SOP covers all primary working standards using in analysis and calibration.

3.0                       Responsibility:

               Jr. Research Officer/ Research officer: qualified the working standard as per STP/ pharmacopoeia, stored as per storage condition and maintain all record.   

               QA Officer/QA Manager: Review the records and governing the document.          

4.0                       Procedure

4.1          Procure the primary working standard from the sources listed in Annexure-1 along with their COA.

4.2          List of primary working standard is as given under Annexure -2 

4.3          Preparation of the Primary Working Standard:

4.3.1       Select an approved batch of respective material and collect the     amount of sample.

4.3.2       Perform the identification, assay / potency in Duplicate, water content / Loss on drying (as applicable) as per the relevant STPs /  Pharmacopoeia methods.

4.3.3                 Consider the average of assay (on as is basis) values for the assay / purity, Precision of the analysed results shall not be more than 0.5 %.

4.3.4     Record the assay / potency (average duplicate), loss on drying / water content in the Working Standard Analytical Report, as given in Annexure – 5.

4.4          After receipt the standard enter the details in primary working standard register, as given in Annexure-3.

4.5          Transfer about 50 gm. From original container in a glass bottle & give the lot number as                             XXX/PRM/001-00.

               Where,     XXX  =    Company Name

                PRM  =    Primary Working Standard ,

                001    =    Primary Standard number

               00    =    Year

4.6          Record the details as per given in Annexure-3.

4.7          Affix the label on the bottle as given in Annexure - 4

4.8        At the time of use take the required quantity as per procedure of standardization and calibration.

4.9         Each primary working standard shall be valid up to twenty-four months. A new primary   working standard shall be procured at the end of validity of earlier primary working standard.

5.0       Documentation:

5.1       Annexure – 1 -      List of source to procure primary working standard

5.2       Annexure – 2 -      List of primary working standard

5.3       Annexure – 3 -      Receipt & Transferred details of primary

                                         working standard                                                   XXX/FRM/000-00

5.4       Annexure – 4 -      Label of primary working standard.                     XXX/FRM/000-00

5.5      Annexure– 5-      Primary Working Standard Analytical Report        XXX/FRM/000-00

6.0              History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision
01	DD/MM/YEAR	Add revision history and defined responsibility.	Periodic review

Annexure – 1
Primary Standards are procured as and when required from the following sources :
Sr. No.	Sources	Supplier
SOP No. : XXX/SOP/000-00

Annexure – 2
List of Primary Standard
Sr. No.	Name of the Primary Standard Chemical
SOP No. : XXX/SOP/000-00

Annexure – 3
Primary working standard Consumption Record Primary Working Standard  : Batch No.                            : Manufactured by                 : Use before                           : Quantity Received               :
Date	Opening Stock in gm	Quantity Transferred for use in gm	Lot No. Assigned	Closing Stock in gm	Transfer      By	Remarks
SOP No. : XXX/SOP/000-00                                                         Format No. : XXX/FRM/000-00

Annexure – 4

PRIMARY WORKING STANDARD Name : PS No. : Manufactured by : Lot No. / B. No. : Use Before :

SOP No. : XXX/SOP/000-00                                                        Format No. : XXX/FRM/000-00

		Annexure – 5
PRIMARY WORKING STANDARD ANALYTICAL REPORT
Name of the Standard :                                                       A.R. No.            : Manufacturer              :                                                        Batch No.         : Mfg. Date                   :                                                        Exp. Date         : Evaluated with           :                                                         Date                 :
WORKING STANDARD NO. :  XXX/PRM/01
TESTS PERFORMED			OBSERVATIONS		LIMITS
Description
Loss on Drying
ASSAY			Assay1 :
			Assay 2:
			Average:
Remarks:       This Standard shall be substituted as working standard in place of the reference standard given above for performing tests only.
Effective From   :				Valid Upto :
Analysed by    :                                   Checked by     :                       Approved by   :             Date                :                                   Date               :                       Date                :
SOP No. : XXX/SOP/000-00                                            Format No. : XXX/FRM/000-00