Procurement And Handling Of Reference Standards


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.

4.0  ACCOUNTABILITY:

4.1  Head of the Q.C 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 USP and BP 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 Reference 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 SOP.

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 2oC to 8oC 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 scarp.

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  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Quality Control Department Bin Card for Reference Standard

Annexure: 1

Quality Control Department Bin Card for Reference Standard

Name of reference standard: __________________________             Ref. No.: ________

Current lot No.: ____________________                 Procured from: _________________

Sr.#

Date of receipt

Qty. Received

(mg)

Date of issue

Qty. issued in mg

Balance qty.

(mg)

Issued by

Date of discard

Lot. No. discarded

Qty. discarded

(mg)

Discard by

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                      

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

 


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