SOP for Handling of Reference and Working Standards

1.0 OBJECTIVE

To lay down a procedure handling of reference and working standards.

2.0 SCOPE

The procedure is applicable for handling of reference and working standards.

3.0 RESPONSIBILITY

Officer/Executive – Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Procurement of reference standard and impurities.
5.2 Reference standard and impurities related to the product shall be procured of IP, USP, BP and In-house Standard.
5.3 Record of all procurement shall be maintained.
5.4 Stock of all reference standard shall be maintained under recommended storage condition
5.5 Usage record of reference standard and impurities shall be maintained.
5.6 Reference standard shall be use development of working standard.
5.7 Working standard shall be prepare by comparative study of purest form raw materials.
5.7.1 For development of working standard by HPLC/UV/Auto titrator three analysis shall be performed using reference standard. Average result of comparative study shall be used for routine analysis.
5.7.2 Use before working standard maximum once in a year or 6 month for less stable products.
5.7.3 12 vials shall be prepared for the use for each working standard for one year period.
5.7.4 Store working standard below 25°C and humidity less than 60% cool and dark place or light-resistant container.
5.7.5 Following details shall be maintained on each vial.

Working Standard

Product  Name  :  XYZ W S No.  :  WS/XX/001 Assay  :  00.00 %  as such basis LOD / Water  :  0.00% Vial No.  :  01 Effective Date  :  DD/MM/YYYY Use Before  :  DD/MM/YYYY Issue date  :  DD/MM/YYYY

Where XYZ is a product name and WS is working standard, XX is a product code, 001 is a serial number, DD date, MM month and YYYY is a year.
5.7.6 All working standard container shall be stored under refrigerated conditions (2°C - 8°C)
5.7.7 One opened vial shall be used only for 30 days from the date of opening.
5.7.8 Each opened vial shall be maintained under desiccators at room temperature.
5.7.9 After 30 days of use the shall be discarded, and a fresh vial will be opened for use and maintained in desiccators.
5.8 All log books/registers shall have an approved printed format.
5.9 The log books/registers shall be issued and maintained on annual basis.
5.10 The details of issue and maintenance of the records shall be with the documentation.
5.11 The record shall be maintained in the documentation cell for reference purpose for 5 years.
5.12 Quality Assurance Manager shall ensure the reconciliation and disposition of the archived log books/registers, and authorize the disposition.
5.13 Details of working standard preparation and use shall be maintained.

6.0 ABBREVIATIONS

6.1 LOD - Loss on Drying
6.2 No. - Number
6.3 W S - Working Standard

ANNEXURE – I

REFERENCE STANDARD

NAME OF MATERIAL__________________________

Date of receiving	Name of Material	Batch/ Lot No.	Grade	Use Before	Quantity. Received	Potency	Water /LOD	Qnty. Used	Qnty. Remains	Sign of Analyst

                                               

ANNEXURE – II

WORKING STANDARD LOG

Name Of Raw Materials ___________________________

Date

AR No.

Batch/ Lot No.

Mfg.date

Exp Date

Use Before

Q.ty. Vials Prepared

Potency

Water /LOD

Effective Date

Sign of Analyst

Checked By

Remarks

ANNEXURE- III

VIAL ISSUANCE RECORD FOR WORKING STANDARD

Working standard ___________________________

Date	Total No of vial Prepared	No of vials  issued	Balance  vials	Issued by	Received by	Remarks

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