The purpose of this SOP to deal with the calibration of instruments, glassware, equipment, thermometers etc.
This SOP is applicable to all analytical and testing equipments/ instruments and glassware in Quality Control laboratory at Pharmaceutical Manufacturing Industry.
PROCEDURE:
PRELIMINARY STEPS
Prepare calibration procedures for all analytical instruments/ equipments as a part of the corresponding standard operating procedures [SOP]. Provide identification code number for all instruments and for all equipments.
Prepare calibration protocols for each instrument/ equipment, setting out the parameters for measurement or observation and provide sufficient space for recording the values obtained or the observation made. Get the controlled copies authorized by the Quality Assurance.
Make an annual schedule for calibrating of each instrument / equipment indicating the dates when the instrument / equipment is to be calibrated.
For all new instruments, calibrate the instrument more frequently (once in three months for a year followed by once in six months), and for existing instruments follow SOP for Calibration.
Prepare display tags for each instrument/equipment indicating the code number, the date of calibration, due date of the next calibration and space for signature of the Analyst who has done the calibration.
ALLOCATION OF CALIBRATION
Follow the procedure for allocation for testing. Make an entry for all the calibrations due in the month.
Calibration of the instrument should be carried out within ± 5 days from the due date of calibration as per schedule.
TESTING AND REPORTING
For instruments/equipments :
Read the relevant SOP and organize the work in such a manner that testing can be completed in the allotted time.
Enter the details in the calibration data sheet.
Carry out the calibration and checks as given in the relevant SOP unless otherwise advised by the section head.
Make all the relevant entries directly on calibration data sheet.
Follow the procedure for instrumental analysis.
After each test, check the raw data and result against the SOP for compliance. When a test result does not comply with the acceptance criteria, inform the Section Head promptly, and if required, on the direction of the Section Head, repeat the test and enter the additional value on the calibration data sheet or where space available is inadequate, on a fresh calibration data sheet duly authorized.
Compile all the papers including the instrument printout (if any) and carry out the checks on all the pages.
Submit the entire set of complete reports along with the calibration file to the QC-Head.
Other Equipment
Volumetric Glassware:
For class A :
Calibration is not required for Class -A Glassware but Class A Certificate is
necessary at the time of receipt.
Thermometers:
Schedule: Carry out the calibration of thermometers once in a year, by outside agency.
Hygrometers:
Schedule: Carry out the calibration of hygrometers once in a year, by outside agency.
Thermometer gauges, pressure gauges :
Have the calibration done by the Engineering Department / External party. Ensure that the calibration records are maintained.
Schedule: Once in a year, by outside agency.
REVIEW OF TEST RESULTS
Carry out the checks on the completed reports of the analysts.
COUNTER CHECKING OF COMPLETED REPORTS
Carry out the check on calibration reports given by the Section Head.
FOLLOW – UP
Update the display attached to the instrument and indicates the completion of the calibration exercise in the schedule and mention the actual date on the schedule.
File the calibration protocol in the relevant file.
In case of non- compliance of results put a tag on the instrument stating ‘Under Maintenance’ and refer the problem to the Service engineer/Engineering department.
After rectification of the equipment, perform the calibration again. If the calibration requirements are met, remove the ‘Under Maintenance’ tag from the instrument and update the display tag.
File the calibration record in the relevant file along with the service report.
TRAINING:
As per SOP On Employee Training
DISTRIBUTION:
As per SOP ON SOP
ANNEXURE:
Nil
REFERENCES(S):
In-house