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SOP for Handling of Reference and Working Standards


Standard operating procedure of handling of reference and working standards used for Pharmaceutical analysis.

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 store under refrigerated conditions (2°C - 8°C)
5.7.7  One opened vial shall be used only for 30 day 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




























Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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