SOP for Calibration Programme : Pharmaceutical Guidelines

SOP for Calibration Programme

Standard operating procedure to prepare the Calibration Programme for Quality Control instruments.


       To define suitable schedule for calibration of Q.C. instruments as per specified frequency.

2.0  SCOPE

       This procedure is applicable to all instruments installed in Q.C. Dept for calibration, performance check and operational check whichever is applicable for respective instrument.


3.1  Doing      : Technical Assistant / Executive.
3.2  Checking : Executive /Manager


       Head of the Department



5.1.1  Calibration of Q.C. instruments falls in two categories.
a.  Internal calibration : Such calibration is carried out by using standards available in laboratory.
b.  External calibration : Such calibration is carried out by third party. (Third party may take Instrument outside premises)
5.1.2  Prepare month wise calibration schedule. This is to be prepared in last week of the month for next month and so on.
5.1.3  Calibration to be carried out as per following frequencies.
           1    +/- 1 day for 15 days  
           2    +/- 2 days for monthly
           3    +/- 1 week for quarterly
           4         15 days for half yearly 
5.1.4  Before starting calibration, check availability and validity of the required standards.
5.1.5  Ensure that all standard chemicals meet requirement of respective pharmacopoeia and use only qualified instruments (if required) for calibration .
5.1.6  Issue the calibration /performance/operational protocol duly sign with ref. no and issued date and maintain the record.
5.1.7  Before starting calibration /performance/operational check, go through respective procedure and protocol. In case of any discrepancy, contact Executive / Manager.
5.1.8  Perform the calibration/performance/operational check as per specified procedure.
5.1.9  After completion of respective check, write down status of instrument on calibration card and sign it.
5.1.10  In case of results are not satisfactory, immediately inform to Executive / Manager.
5.1.11  Write down all observations/ results in respective protocol  and take approval of authorised person.
5.1.12  Before approval of record, authorised person will check all the calculation and ensure that  calibration is carried out as per standard procedure and results are satisfactory within specified limits.
5.1.13  Make entry by ‘(√ )‘ marking in calibration schedule.


5.2.1  Ensure that standard operating procedure for calibration is followed.
5.2.1  Check that all the calculations are correct. (If applicable)
5.2.2  Ensure that right standards are used for calibration.
5.2.3  If calibration/operational/performance check of instrument does not found satisfactory and error is not identified, label the instrument as ‘Out of Calibration’         
5.2.4  Inform to instrument engineer regarding the problem.
5.2.5  To check the validity of the testing carried out of all the samples which have been tested on particular instrument after last calibration and before calibration failure, collect following data for further action.
a.  Frequency of calibration
b.  Whether the previous calibration done according to the schedule.
c.  Results of previous calibration.
d.  Confirm the validity of standards used      
e.  Check for replacement of any major parts / parameters ,after previous calibration.
5.2.6   Carry out retesting of samples tested recently (starting from last sample) before this calibration till three consecutive samples shows the difference within 2 %  w.r.t. previous results, giving priority to finished product sample.         
5.2.7  In case of difference is observed more than 2% , reanalysed  the samples and document it.
5.2.8  Enter all the data in tabular format for evaluation.
5.2.9  Q.C. head will review the data and give the final conclusion. 


6.1  % = Percentage
6.2  Q.C= Quality control
6.3  w.r.t.= With respect to
6.4  SOP - Standard Operating Procedure

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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