SOP for Procurement and Handling of Reference Standard

1.0 OBJECTIVE

To ensure the availability of reference standard and have an accountability of the same.

2.0 SCOPE

This procedure is applicable for all the reference standards of different pharmacopoeia.

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant /Executive
3.2 Checking : Head of the Department

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Get the latest list of the reference standard from the respective agencies for the current lot.
5.2 Procure the reference standard of U.S.P., B.P., E.P. and I.P. from respective agencies or as mentioned in the respective pharmacopoeia by placing a purchase order.
5.3 On receipt of the reference standard, check all the details on the label and enter the respective detail in the bin card to maintain a stock of the same as per Annexure-I for reference standard and impurity standard.
5.4 Assign the Ref. number for Ref .std. and impurity standard as follows.
For Ref. Impurity standard
RIA01 

Where, RI = Reference impurity
A = Alphabet of Ref. impurity
01 = serial number of receiving ref. Impurity for each alphabet
For Ref. standard
RSA01 

Where, RS = Reference standard
A = Alphabet of Ref.standard
01 = serial number of receiving ref. standard for each alphabet
5.5 The Executive/Manager shall ensure that the bin card is maintained and entry is done after each withdrawal.
5.6 A working standard shall be prepared using the reference standard as per S.O.P.
5.7 The Executive/Manager shall ensure the availability and procurement of reference standard well in advance.
5.8 Reference standards shall be properly closed and stored in the refrigerator at 2°C to 8°C temperature.
5.9 Discard the old lot of reference standard on implementation of current lot.
5.10 Procedure for Discard
5.10.1 Empty the contents in waste beaker containing water. After the material gets soften, decant the water & transfer the paste into the polyethylene bag. This paste is then sent to scrap.
5.10.2 Deface the labels of the reference standard vial or ampoules.
5.10.3 Discard the vial & ampoule in to the dustbin for broken glass ware .
5.10.4 Record the destruction detail of reference standard & Impurity standard in Annexure-I.

6.0 ABBREVIATIONS

6.1 I.P.= Indian Pharmacopoeia
6.2 B.P.= British Pharmacopoeia
6.3 U.S.P. = United State Pharmacopoeia
6.4 E.P = European Pharmacopoeia
6.5 Ref.= Reference
6.6 Std. = Standard

 Annexure-I

QUALITY CONTROL DEPARTMENT 

BIN CARD FOR REFERENCE STANDARD

NAME OF REFERENCE STANDARD :____________________________  REF.No.:________

CURRENT LOT NO.:___________________ PROCURED FROM : ____________________

Sr. No.	Date of Receipt	Qty. Received ( mg)	Date of issue	Qty. issued in mg	Balance Quantity (mg)	Issued by	Date             of Discard	Lot. No. Discarded	Qty. discarded ( mg)	Discard By.

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