Calibration Of Disintegration Test Apparatus
1.0 Objective
To lay down a guidelines for Calibration of Disintegration Test Apparatus in Quality Control Department.
2.0 Scope
This SOP applies to Calibration of Disintegration Test Apparatus used in Quality control Lab in A B C Company.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
C : Calibration
5.0 Procedure
5.1 First check the instrument is free from dust and foreign matter.
5.2 Now on the Switch of main supply then on the switch of the instrument.
5.3 Fill the beaker with distilled water
5.4 Maintained the temperature in specified monograph.
5.5 Count the cycles of instrument per minutes and read the temperature of medium, Which is kept in the Beaker by the help of calibrated thermometer.
6.0 Forms and Records
6.1 Calibration Certificate of Disintegration Apparatus – Annexure-1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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Calibration Of Disintegration Test Apparatus