Procurement & Handling Of Reference Standards

1.0    PURPOSE:

1.1    To lay down the procedure for Procurement & Handling of Reference standards.

2.0    SCOPE:

2.1    This SOP is applicable for all reference standards used in Quality Control Department.

3.0    RESPONSIBILITY:

3.1    Sr. Executive – QC 

4.0    ACCOUNTABILITY:

4.1    Incharge – QC 
4.2    Asst. Manager – QC 

5.0    PROCEDURE:

5.1    Definition:

5.1.1    Reference standards are specifically required for analysis to attain accurate and reproducible results.  They are substances of high purity and are used for the evaluation of working standards, which are intended for the routine analysis.
 
5.2    Official Sources of Pharmacopoeial Reference standards:

5.2.1    Refer Annexure I.

5.3    Procurement:

5.3.1    Purchase indent shall be raised for the pharmacopoeial reference standards.
5.3.2    Receive the reference standards like EPCRS/USPRS/BPRS/JPRS against purchase indent.
5.3.3    Check the reference standards container for integrity, label details like Purity, Lot.No and storage condition.
5.3.4    Record the receipt in “Reference standards receipt entry and usage logbook”, as per the format No.: xxxxx-F01
5.3.5    Use the reference standards for generating of working standards, for resolution mixture preparations and for identification purposes.

5.4    Storage and Handling:

5.4.1    Reference standard shall be stored in original airtight containers in a refrigerator (Between 2° C and 8° C).
5.4.2    Takeout reference standard from the refrigerator, keep it outside and allow it to attain ambient temperature and proceed for weighing.
5.4.3    Read the instructions given on the reference standard label and follow it strictly before use.
5.4.4    Open the vial carefully.  Keep the stopper in the inverted position on a clean butter paper.  Do not use the stopper if it is contaminated. Replace with cleaned stopper.
5.4.5    Use a clean Stainless Steel spatula for transferring the sample.
5.4.6    Where drying is recommended, a small quantity, sufficient after drying, should be transferred to a clean dry container.
5.4.7    After the weighing is completed replace the stopper and store in the recommended storage conditions.
5.4.8    The original container should not be used, as the drying vessel and a specimen of the substance should not be dried repeatedly at temperatures above 25°C.
5.4.9    Where a titrimetric determination of water is required at the time of use, a micro analytical or instrumental method using a minimum quantity of Karl Fischer reagent diluted four-fold is recommended.
5.4.10    Record the usage in  “Reference Standards Receipt Entry and Usage Logbook”, as per the format No.:xxxxx-F02.
5.4.11    The reference standard shall be considered as 100% unless a potency or purity is specified in the reference standard container label.

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