SOP for Procurement and Handling of Reference Standard : Pharmaceutical Guidelines

SOP for Procurement and Handling of Reference Standard

Standard operating procedure to handle the Official Reference Standards and Reference Impurities.

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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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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