SOP for Preparation of Working Standard and Referance Standard.

1.0                    Objective:

               To provide written procedure for handling of Reference Standards, usage and           preparation of working standards.

2.0                       Scope:

               This SOP covers all Reference Standards and Working Standards usage in analysis.

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 which is required.

               QA officer/QA Manager: evaluate the data and give the approval.

4.0                       Procedure:

4.1          Obtain the details of current lots of Reference standards from authorized dealers of Reference Standards or from Pharmacopoeia Forum, etc.

4.2          Procure Reference Standards from the sources listed in Annexure - 1 or manufacturers. Enter the details in the Reference Standard register, as given in Annexure - 2 at the time of receipt and subsequent usage.

4.3          Store the reference Standards in their original containers protected from heat, light and moisture and keeps them in a refrigerator (2⁰ C to 8⁰ C) or as directed on the container.

4.4          PREPARATION OF WORKING STANDARDS:

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

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

4.4.3                 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 %.

4.4.4                 Record the assay / potency (average duplicate), loss on drying / water content in the Working Standard Analytical Report, as given in Annexure – 3.

4.4.5                 Record the details in the Working Standard register, as given in Annexure - 4.

4.5          Sub divide the material and transfer to screw capped, glass bottles / vials store in a

              refrigerator / desiccators, as applicable, away from heat, light and moisture after labeling.

4.6          Label the individual Working Standard with label as given in Annexure - 5.

4.7          Each working standard shall be valid up to twelve months.

4.8                       A new Working Standard shall be prepared and Standardized at the end of validity of earlier Working Standard. If a new material is not available, the existing Working Standard shall be standardized and appropriate validity assigned (which should be within the expiry date of material).

4.9                       Working Standard shall always be standardized using Reference Standards.

4.10     When a Reference Standard or working standard is not available we asked party to provide working standard.

4.12                   Whenever a new lot of Reference Standard is procured, the current Working Standard shall be re-standardized against the new lot of Reference Standard.

5.0          Documentation:

5.1          Annexure – 1 - Reference Standard source list.        

5.2          Annexure – 2 - Reference Standard register.                                 XXX/FRM/000-00

5.3          Annexure – 3 - Working Standard Analytical report format.         XXX/FRM/000-00

5.4          Annexure – 4 - Working Standard register.                                   XXX/FRM/000-00

5.5          Annexure – 5 - Working Standard label.                                       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

Reference Standards are procured as and when required from the following sources :

SOP No. : XXX/SOP/000-00

Annexure – 2
Sr. No.	Name of the Reference Standard and make	Date of Receipt	Purity	Lot No.	Quantity Received	Opening Balance	Date of Opening	Quantity Withdrawn	Closing Balance	Sign.	Remarks
SOP No. : XXX/SOP/000-00                                                                                                                                        Format No. : XXX/FRM/000-00

Annexure – 3
WORKING STANDARD ANALYTICAL REPORT Name of the Standard            :                                              A.R. No.           : Manufacturer              :                                                         Batch No.          : Mfg. Date                   :                                                         Exp. Date          : Evaluated with            :                                                         Date                  : WORKING STANDARD NO. :  _____________________
TESTS PERFORMED	OBSERVATIONS	LIMITS
REMARKS :  This Standard shall be substituted as working standard in place of the reference standard given above for performing tests only. Effective From   :                                                                               Valid up to :     Analysed by    :                                   Checked by     :                       Approved by   :             Date    :                                               Date    :                                   Date    :
SOP No. : XXX/SOP/000-00                                                           Format No. : XXX/FRM/000-00

Annexure – 4
Sr. No.	Name of the Standard	Date of Standardisation	Evaluated with	Working Standard No.	A. R. No.	Effective from	Assay (As is)	Valid up to	Analysed by	Checked by	Remarks
SOP No. : XXX/SOP/000-00                                                               Format No. : XXX/FRM/000-00

Annexure – 5

WORKING STANDARD Name : WS No. : Assay :                                   (As is) LOD/Water : Use Before : Prepared by : Storage Condition :

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