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.
This SOP is applicable for identifying stability and use before period of volumetric solution prepared
- Officers / Executive – Quality Control.
- Manager – Quality Control and Head QA shall be accountable for compliance of this SOP.
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
- 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:-
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.
SOP: Standard Operating Procedure
QC: Quality Control
VS: Volumetric Solution
QA: Quality Assurance
- DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
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- DISTRIBUTION LIST
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