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Page Contents
1. Purpose
This procedure describes conditions pertaining to an adequate and organized calibration system of measuring devices.
2. Scope
This SOP is applicable for the Calibration Of Instruments at the Pharmaceutical plant
3. Responsibility
QA Officer
QC analyst
Production Manager
QC Manager
4. Calibration Of Instruments Procedure
4.1 Upon receipt, all equipment should be reviewed by the Q.A officer and the user department to establish if the equipment has to be kept on calibration program.
4.2 Inclusion and exclusion lists should be maintained with reasons, location, and final approval by the Q.C/Production manager.
4.3 Classification of equipment as critical or noncritical with regard to calibration
necessities should be maintained.
4.4 The equipment variables affecting the product quality shall be identified
as critical for calibration.
4.5 Determination of accuracy requirements of the instrument should be in
consent with the quality assurance and calibration departments.
4.6 Calibration of the instrument should be on time prior to the expiration of calibration
date by informing the calibration department.
4.7 New, changed, or repaired instruments should be prior to using.
4.8 Tasks of Calibration Department
4.8.1 Decide which instruments can be calibrated internally and which have to be calibrated by subcontractors.
4.8.2 Purchase and control measuring equipment and reference material necessary
for internal calibration certification of calibrated instruments. Label
them with the date when last calibrated and also the date when the next
calibration is due. Write a calibration report and, if necessary, an incident
report or a calibration variance report.
4.8.3 Always follow calibration and operation SOP of each equipment/instrument.
4.9 Reference Standards
The reference standards used for calibration of instruments should be checked for
accuracy annually by an authorized measuring institution (e.g., Office of Weights
and Measures or Bureau of Standards). The reference standard employed should
have an uncertainty of measurement which is 1/10 to 1/5 the uncertainty required
in the measurement equipment.
4.10 Cumulative Effect of Errors
The uncertainties of all equipment used in the calibration procedure and the method
of combining them should be shown on the calibration certificate.
4.11 Training of Personnel Performing the Calibration Work
Only trained personnel should be employed for performing the calibration work.
The above requirements are applicable for subcontractors performing calibration
work on behalf of your company. Outside calibration laboratories should be
inspected.
- Intervals of Calibration
All critical items/Processes should be calibrated every 06 months. Noncritical items should be
calibrated every 12 months. If necessary, recalibration frequency should be reviewed
and revised.
- Periodic Review of the Calibration Program
Periodic review of the calibration system should happen once a year using an
established inspection checklist.
5. Calibration of Volumetric Glassware
5.1. Burettes, Pipettes, and Volumetric flasks must be calibrated for their accuracy in measurement upon receipt.
5.2. Calibration should be carried out at 27°c.
5.3. Fill the Burette/Pipette/VF to its standard mark with distilled water.
5.4. Drain the water into a clean and previously weighed bottle & weigh the bottle.
5.5. Calculate the volume of water drained by the following formula.
The volume of water drained = Wt.of water in g
0.99602(Density of water)
5.6. The glasswares under test are accepted if they comply with limits specified in tables.
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