Shelf Life of Chemicals and Reagents

  1. Objective

To lay down the procedure for Shelf Life of Chemicals and Regents.

  • Scope

The SOP is applicable for shelf life of chemicals and regents.   

  • Responsibility

Chemist QC                      : To follow the procedure                                           

  • Accountability:

Head QC               : System Compliance  

  • Procedure
    • If Items and quantities are satisfactory then affix the pre printed label on every container . Length of the label shall be 3.5 cm and width shall be 2.0 cm.
    • Each chemical and reagent shall be given an expiry based on manufacturer recommendation. In case no expiry date is recommended by the manufacturer, five years expiry dates shall be assigned from the date of manufacturing.
    • Write the use before date as described below:
      • For Liquid Chemicals and Solvents:

The use before date for liquid chemicals and solvents are 2 years from the date of opening or the manufacturer expiry dates whichever is earlier.

  • For Primary Standards:

The use before date for primary standards (Liquids & Solids) is 2 years from the date of opening or the manufacturer expiry date whichever is earlier.

  • For Indicators:

The use before date for indicators is 3 years from the date of opening or the manufacturer expiry date whichever is earlier.

  • For Solid Chemicals:

The use before date for solid chemicals is 3 years from the date of opening or the manufacturer expiry date whichever is earlier.

  • For Hygroscopic Chemicals:

The use before date of hygroscopic chemicals is 1 year from the date of opening or the manufacturer expiry date whichever is earlier.

  • Arrange the Chemicals in the chemical store in the respective rack.
    • At the time of issuance make the entry on the label at the place of date of opening on container.
    • Discard the container if any of following is observed.
  • Change in physical appearance.
  •  Appearance of any turbidity or precipitation.
  • Any smell observed which is not characteristic to that particular material.
  • Any contamination is observed in chromatographic analysis.
  • If by using the material of a particular container/ Lot, analyst does not get satisfactory / Characteristic results, whereas on using another container /Lot analyte get satisfactory /Characteristic results, in any such case reject the container/Lot and reanalyse the sample with a fresh Lot/ Container.
    • At the end of the month checks for the physical stock.
  • Annexure (S)

NA

  • Reference (S)     

In house

  • Glossary

SOP          : Standard Operating Procedure.

QC             : Quality Control

QA             : Quality Assurance

NA             : Not Applicable

  • Revision History
Rev. No. Details of changes Reason for change
 

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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