Handling of Reference and Working Standard SOP

Standard Operating Procedure of Handling of Reference and Working Standard SOP is describe in this post.

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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 at Pharmaceuticals.

3.0 RESPONSIBILITY:

3.1 QC Analyst.

3.2 QC Manager.

4.0 ACCOUNTABILITY:

4.1 Head of the Q.C Department.

5.0 PROCEDURE:

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 ANNEXURES:

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

GRN  No.

Batch/

Lot No.

Mfg. date

Exp. Date

Use Before

 

Qty. Vials

Prepared

Potency

 

Water

/LOD

Effective

Date

Sign

of

Analyst

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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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