1. Noor Nabi
Deputy Manager Validation

2. What Is Calibration?
Calibration is the process in which the values of any device or instrument are
compared with reference standards whose values are accurate & known.
Example
To calibrate the balance we place standard weights on the balances & readings are
recorded. If The reading displayed on balance is the same as the value of the
reference standard weight then we declare that our balance is calibrated.

3. Importance Of Calibration
Accuracy
The critical operations which involve measurements are greatly dependent on the
accuracy of the measuring device. If the device is calibrated we can claim that our results
are accurate.
Product Quality
If a product is manufactured using calibrated measuring devices it assures us that our
product is of high quality.
Precise Results
By using calibrated devices we get precise results.
Reduce Cost
By using timely validated devices the down times are reduced (which may occur due to
faulty readings) & cost of operation is also reduced.

4. When To Perform Calibration?
 Before first time usage of a new device or instrument.
 After the due date, recalibration is done.
 According to manufacturer specifications.
 To meet regulatory requirements.
 In case of any shock or damage.
What Is Calibration Frequency?
Calibration frequency is the duration after which the device or instrument is
recalibrated, also known as Calibration Interval Or Calibration Due Date.

5. How To Determine Calibration Frequency?
Now we will discuss how calibration interval or calibration frequency is
determined Or in simple words how an organization sets a calibration
duration for a device or equipment.
We will divide it into 2 parts,
 Initial Calibration Interval
 Final Calibration Interval

6. Initial Calibration Interval
Initial calibration interval or frequency is the period which is set for the first time for any
instrument or device.
Most Pharmaceutical industries use ls traditional fixed initial calibration intervals like
 Bi-Annual
 Annual
 After Two Years
Some Pharma uses one year as an initial calibration frequency for those devices which are used
for less critical operations & twice a year for those which are used for critical processes.
Best Practice
The best practice to determine calibration interval is based on the following,
 It is initially defined based on expert advice.
 It is defined based on previous experience with such an instrument.
 Based on manufacturer recommendations.
 Based on regulatory requirements.
 Nature of work for which it is used.
 Frequency of use.

7. Final Calibration Interval
The initial calibration frequency is not final; it is set only to get data for a specific
period. When we have sufficient calibration data for a specific device we compare
different values of past data and check the trend of values or results.
If all the values are within the limit from start to end we may increase the initial
validation duration.
If values show variation we may decrease the duration
When Calibration Frequency Can Be Decreased?
As calibration is performed by third parties it increases the cost of the organization so
here we will discuss the cases where the calibration frequency can be decreased to
reduce the cost & men power involved.
The calibration frequency can be decreased in following situations.
 When the tolerance of calibration results is within range.
 When the device or equipment is used for less sensitive or non-critical operations.

8. When Calibration Frequency Can Be Increased?
Can be increased in the following cases,
 When the drift of a device or instrument is out of defined ranges.
 When the device shows significant drift in past results.
 When the device is placed in a critical area.
 When the results of a device may significantly affect the product quality.
 When the equipment is used in an area where temperature, humidity or vibrations may
affect the performance.