SOP FOR STABILITY OF VOLUMETRIC SOLUTIONS

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  • OBJECTIVE

To lay down a standard the procedure for Evaluation of Stability studies of volumetric solution and confirmation of use before period of the volumetric solution.

  • SCOPE

This SOP is applicable for identifying stability and use before period of volumetric solution prepared

  • RESPONSIBILITY
    • Officers / Executive – Quality Control.
  • ACCOUNTABILITY
    • Manager – Quality Control and Head QA shall be accountable for compliance of this SOP.
  • ATTACHMENTS

Format for stability of volumetric solutions                                          Attachment-I

Format for List of Volumetric solutions under stability study          Attachment-II

Format for Report of stability of volumetric solutions                       Attachment-III

  • PROCEDURE
    • Shelf life of volumetric solutions shall be determined by quality control department before releasing the volumetric solution for routine analysis.
    • For determination of Shelf Life, Quality Control Department shall prepare respective stability Protocol & Report for Individual volumetric solutions.
    • Protocol & Report shall be prepared by Officer / Executive Quality control, reviewed by Manager Quality Control and approved by Manager Quality Assurance.
    • Officer / Executive Quality Control shall prepare the list of most commonly used volumetric solutions for shelf life determination. (Format-
    • Officer / Executive Quality Control shall assign a unique code number for each volumetric solution as given below:-

VS-0000

6.6    Where VS for volumetric solution, first and second 0 stands for last two digit of year, third and fourth 01 stands for specific code No. for individual volumetric solution. (Start from 01)

Ex. – first volumetric solution shall be numbered as

  • Officer / Executive Quality Control shall assign a unique protocol number for each protocol & report as given below (Refer Format-
  • Protocol shall be prepared on the approved format. (Refer Format- .
  • Protocol Report shall be prepared on the approved format. (Refer Format-
  • After preparation, review and approval, the protocol & Report shall be issued for further use.
  • Quality Assurance department shall issue the protocol & Report to Quality Control Department.
  • Quality Control Officer / Executive shall study the stability of volumetric solution as per respective protocol and shall record the observations accordingly in report.
  • Protocols shall be reviewed when the method for preparation or standardization of solution is amended by Pharmacopoeia or In–house.
  • Any change in Protocol shall be done through change control procedure.
  • REFERENCES

         In-house

  • ABBREVIATIONS

         SOP: Standard Operating Procedure

QC: Quality Control

VS: Volumetric Solution

FT: Format

QA: Quality Assurance

  • DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION

Version No. Date of Revision Reason for Revision

 

  • DISTRIBUTION LIST
Sr. No. Copy No. Department

 

SOPs