1.0 OBJECTIVE:To lay down the procedure for Handling of Reference standard and management of Working standard.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance.
5.1 Reference Standard Management:5.1.1 Procure reference standard from authorized sources for preparation and standardisation of working standard. Write the details in the register and maintain the Certificate of Reference standard.
5.1.2 Store all Reference standards in tight containers protected from heat, air, moisture and light and keep them in a properly greased vacuum dessicator containing self indicating dried silica gel at the bottom.
5.1.3 Store the dessicators in an air conditioned place.
5.2 Preparation of working standard:5.2.1 Select an approved batch of respective raw material. Collect the required amount of sample and mix thoroughly.
5.2.2 Carry out tests as per protocol. Perform assay five times. RSD of the five values of assay shall not be more than 2.
5.2.3 Compare the analysis results with Reference standard / Supplier’s working standard (if Reference standard is not available) as per the following procedure:
a) Reference standard is available
i) Compare identification test (IR/HPLC/TLC ) of the raw material against reference standard.
ii) Carry out assay of the raw material taking reference standard as standard whenever possible.
b) Supplier working standard is available.
i) Compare identification test results and purity results (IR/HPLC/TLC) of selected raw material against Supplier’s working standard.
ii) Carry out assay of the raw material Considering Supplier’s working standard as standard.
5.2.4 The final certificate of Analysis for working standard shall have the following details : Name of material, Batch no., Mfg date, Exp date, Mfg by, AR. No., Date of opening, Use Before, Storage conditions etc.
5.2.5 Each working standard vial shall also be labeled with the above details.
5.2.6 Each vial of working standard shall contain not more than 5 gms of the working standard.
5.2.7 No vial shall be used after two months from the date of opening.
5.2.8 Consumption record shall be maintained whenever a working standard is used.
5.2.9 No working standard shall be used for more than two years or when it gets consumed, whichever is earlier.
5.2.10 Each lot of working standard shall be evaluated once in two years.
6.0 ABBREVIATION:6.1 SOP : Standard Operating Procedure
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