handling of working standard
1.0 OBJECTIVE
1.1 To lay down a Procedure for handling of working standard in Quality Control Department.
2.0 SCOPE
2.1 This procedure is applicable for handling of working standard.
3.0 RESPONSIBILITY
3.1 QC Officer or QC Executive
4.0 ACCOUNTABILITY
4.1 QC Manager
5.1 PROCEDURE
5.1.1 Select latest approved batch of Raw material preferably having maximum purity and minimum
Impurity level.
5.1.2 Collect the required quantity of material from the selected batch.
5.1.3 Prepare at least 5 vials of working standards and each vial containing about 2 grams or
Minimum sufficient quantity of material.
5.1.4 Give the reference number to working standards as follows.
XXXX/WS-001
Where A
XXXX : company name
WS : Working Standard
001 : Serial Number of working standard
5.1.5 If the second working standard of same material has to be prepared in the same current year then
different serial number shall be assigned to this standard
5.1.6 Carry out the following test for preparation of working standard.
1. Description
2. Loss on drying/Water content
3. Assay
5.1.7 Carry out Assay determination against reference standard wherever possible
5.1.8 For testing of working standard whose authentic reference standard, reference impurity, testing facility etc.
is not available for testing in the laboratory, that material is sent to outside NABL accredited laboratory for testing.
5.1.9 Enter the results in the protocol of the respective material in any of the case mentioned
Above and attach the Photocopy of original C.O.A. with the protocol.
5.10 Calculate the average of 3 assay values obtained on as such basis.
5.11 Store the material in light resistant & air tight containers.
5.12 Label the vials with the following details
1. Name of working standard
2. Working std no.
3. Potency
4. Valid up to
5.13 Assign one-year shelf life for working standard after six months check the stability of working standards (by
duplicate analysis).
5.14 Make Store all additional vials of working standard in refrigerator (Between 2 to 8oC) as per the list
Prepared in Annexure-I. (List of working standards).
5.15 Keep one vial of each working standard in the desiccators containing Silica.
5.16 Maintain the usage record of working standard as per Annexure – I
6.0 ABBREVIATIONS
| Abbreviation | Extended Form |
| QC | Quality Control |
| SOP | Standard Operating Procedure |
| mg | milli gram |
| gm | gram |
| No | Number |
| WS | Working Standard |
| Ref No | Reference Number |
r
Annexure-1
List of Working Standard
| Sr. No. | Name | WS ID No |
