Wednesday, December 1, 2010

Handling Of Reference Standards Preparation and Handling of Working Standards

1.0   Purpose     : To provide instructions for Preparation and Handling of Reference Standards and Working Standards.

2.0  Objective   : To provide a documented procedure for Preparation and Handling of Reference Standards and Working Standards.

3.0   Scope           :   This will provide procedure for Preparation and Handling of Reference Standards and Working Standards in QC Department of ---Pharmaceutical. Ltd, 

4.0    Responsibility :
·      Primary     : QC Chemist
·      Secondary : Overall: QC Officer

5.0    Procedure  :

5.1            Handling Of Reference Standards:
5.1.1      Procure reference standards from approved vendors.
5.1.2      After receiving the reference standards, enter the details of reference standards in the format as given in Enclosure-1.
5.2            Preparation and Handling of Working Standards.
5.2.1      For preparation of working standard, select a batch of respective material, which has been approved recently. Standardize this batch against the reference standard.
5.2.2      Perform the Assay and Water (by KF) / Loss on drying (whichever applicable) in triplicate.
5.2.3      The average of three results shall be used to determine the assay value. The RSD of 3 Assay values shall not be more than 1.0 %.
5.2.4      Record the analysis details in the working sheet for working standard (Refer Enclosure-2).
5.2.5      Record the details of working standard in the format as given in Enclosure – 3.
5.2.6      Prepare two bottle of each working standard, containing about 25gms, seal and label them.
5.2.7      The label shall contain the following details:
            1.  Working Standard Number 2. Name of Working Standard 3. Assay 4. Water / LOD
5.  Prepared on   6. Use before 7. Prepared by 8. Opened on – Date & Sign.
5.2.8      On the opening of the bottle, the Analyst shall mention the date of opening on bottle.
5.2.9      The Working Standard shall be used within one year, from the date of Standardization.
5.2.10  The new Working Standards shall be prepared before the expiry of the existing working standard.
5.2.11  A history sheet of each Working standards shall be maintained in the format given in Enclosure – 4.
5.2.12  Working Standards shall always be standardized against reference standards. If reference standards are not available, working standard shall be standardized against standards received from R&D.
5.2.13  Refrigerated vials should be brought to room temperature before use.
5.3            Storage and Consumption:
5.3.1      The working standard bottle, which is in use, shall be stored in Desiccator with self-indicating (color) silica gel at room temperature. Store the remaining bottle of working standard and Reference standards in refrigerator at 2-8°.
5.3.2      Self-indicating (color) silica gel can be used up to one year. If the color of Silica gel is changed from blue to white, it shall be dried at 105°C, till the color of silica gel becomes blue.
5.3.3      The vials remaining after one year shall be destroyed as per the procedure given SOP No. QC/SOP/016
5.3.4      The consumption record of the reference standard shall be maintained in the register (Refer Enclosure - 5).
5.4            Numbering System For Working Standard:
5.4.1      All the working standards shall be numbered as per the following number system:
Example: The number of Mebendazole working standard is XXXYYZZ
XXX – For working standard.
                                    YY– Item Code for materials
                                    ZZ – Working standard preparation no. of those materials

Recording Details of Reference Standards                                                                                                                                                 

                                                                                                          QC/SOP /032/F-1


Batch/ lot no.
Ph. Ref.
Water / LOD
Date recd.
Storage condition

Working Sheet for Working Standard

                                                                                                                                                            QC/SOP /032/F-2

Material Name
Batch no.
Mfg. Date
Exp. Date

S. No

Description of Material

Water / LOD.





% Assay (On As is basis)





                   Analyst:                                       Checked by. :                                Approved by. :

Recording Details of Working Standard

QC/SOP /032/F-3

Batch no.

Manufacturing date

Expiry date

Working Std. No.

Standardization date

Loss on drying / Water


Valid up to


                 ANALYSE BY                                                                                      APPROVED BY

HEAD –QC                                                                           Head-Q A

History Sheet of Working Standard

QC/SOP /032/F-4


History Sheet for _________________________ Working Standard.

Date Prepared
LOD/ Water
WS No.
Quantity prepared
Valid upto

Consumption Record for Reference Standard

QC/SOP /032/F-5

Name of Reference Standard:

Sr. No
Lot. No
Date of use
Quantity used

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