- 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 |