CALIBRATION OF INSTRUMENTS

SOP CALIBRATION OF INSTRUMENTS

 

OBJECTIVE :
To define the procedure for calibration of the Laboratory Instruments to check the accuracy and reproducibility of the results.

 

SCOPE:
This procedure is applicable for Calibration of Laboratory Instruments to check the accuracy.

REFERENCES:
i) Instrument Manual.
ii) Pharmacopeia
iii) In-House.

RESPONSIBILITY:
QC – officers, executives – To follow the procedure as per SOP.
QC Head – To ensure proper execution of SOP.
QA – To ensure SOP is being properly implemented.

DISTRIBUTION:
N.A.

ABBREVIATION:
SOP – Standard operating procedure,
QC – Quality Control,
QA – Quality assurance,
N.A.- Not applicable.

 

PRECAUTION:
1. Each instrument used should be calibrated.
2. Instruments out of order or under maintenance or under installation should be indicated with proper label.

PROCEDURE:

1. Make a list of instruments with name, make, capacity, model no. Sr. no.etc.
2. Prepare schedule for instruments to be calibrated. This shall include the name of the instrument, Instrument ID, frequency of calibration.
3. Calibrate the individual instruments as per the respective SOPs and make entry in Log Book as per Annexure.
4. In-house calibration shall be done within 5 days before or after the calibration due date.
5. Calibration by outside agency shall be done within 15 days before or after the calibration due date.
6. Record the observations in individual instrument calibration data sheets as per respective SOPs.
7. If the observation of calibration are within the tolerance limits. Update calibration status label to the instrument. The “CALIBRATION STATUS LABEL” shall include the details like Instrument code No., Calibration done on, Calibration due on, Calibration Done by.
8. If the observations are not within the limits, repeat the calibration procedure to confirm the results. If the results are still out of limit, inform to Q.C. Manager and Q.A. manager they will call service engineer, get the instrument repaired. Meanwhile put label “UNDER MAINTENANCE” with date on instrument.
9. After servicing / repairing calibrate the instrument. If the observations are still out of limit, Manager Q.C. will decide the line of action.
10. Instrument like pH meter calibrate on daily basis, Electronic weighing balance verify daily and monthly as per S.O.P
Monthly calibration due date shall be assigned as follows:
i) For e.g. Weighing will be calibrated on Monthly basis, if it is calibrated on 02/01/2013 its next due date is 01/02/2013.
11. Instrument like F.T.I.R, U.V. spectrophotometer, Automatic Potentiometer Titrator, Melting point apparatus, tap density apparatus, Leak apparatus, are calibrated on Quarterly basis. Mention the date, the standard used, the observation and particular adjustment made on calibration records.
Quarterly calibration due date shall be assigned as follows:
i) For e.g. F.T.I.R will be calibrated on quarterly basis, if it is calibrated on 02/01/2013 its next due date is 01/04/2013.
12. H.P.L.C. calibrated on Half yearly basis.
If it is calibrated on 02/01/2013 its next due date is 01/07/2013.
13. Instrument like Muffle furnace, oven & water bath calibrated on yearly basis.
i) For e.g. Muffle furnace will be calibrated on yearly basis, if it is calibrated on 02/01/2013 its next due date is 01/01/2014
14. Counter check the calibration records by the Manager Q.C.
15. Any out of calibration observation should be informed to Q.A. for corrective action.

ANNEXURE:
16. Annexure I: Monthly, Quarterly, six monthly & Yearly Calibration planner
17. Annexure II: Calibration & validation schedule

 

 

Annexure I    

Monthly, Quarterly, Six monthly  & Yearly Calibration Planner  (Year –    )

Name of the

Instrument

Instrument

Code No.

      Month

Calibration

JANFEBMARAPRMAYJUNJULAUGSEPTOCTNOVDEC 
 

Due on
             
Done on             
Next Due Date             
 
Due on
             
Done on
             
Next Due Date
             
  
Due on
             
Done on
             
Next Due Date
             

 

Prepared By                            Reviewed By                                         Authorized By

Q.C. officer                             Q.C. manager                                        QA Incharge

 Date :                                     Date :                                                    Date:

 

 

Annexure II

Calibration & validation schedule (Year –     )

Sr. NoInstrument Name Instrument Code No.Calibration or validation
DailyMonthly Quarterly Six monthly Yearly
        
        
        
        
        
        
        
        
        

 

Prepared By                            Reviewed By                                         Authorized By

Q.C. officer                             Q.C. manager                                        QA Incharge

 Date :                                     Date :                                                    Date: