In this slide contains Calibration vs Qualification and phases of qualification. Presented by: A.Siddartha Tharun Teja. (Department of industrial pharmacy). RIPER, anantapur.

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
CALIBRATION vs QUALIFICATION
A Seminar as a part of curricular requirement
for M. Pharm I year I semester
Presented by
A.Siddartha Tharun Teja
Reg. No. 20L81S0804
Department of Industrial Pharmacy
Under the guidance/Mentorship of
Dr. Hindustan Abdul Ahad M.Pharm Ph.D FAGE
Professor & Head of Dept. of Industrial Pharmacy

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
• Calibration
• Need for calibration
• Importance of calibration
• Qualification
• Categories of Analytical Instruments.
• Phases of Qualification
• References
Contents

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
• Calibration of an instrument is the process of determining its accuracy.
• The process involves obtaining a reading from the instrument and measuring
its variation from the reading obtained from a standard instrument.
• Calibration of an instrument also involves adjusting its accuracy and
precision.
• Calibration achieves 2 main objectives—
(a) It checks the accuracy of an instrument.
(b) It determines the traceability of the measurement.
Calibration

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
Need for Calibration
Calibration can be done when
•With a new instrument.
•When a specified time period is elapsed.
•When a specified usage (operating hours) has elapsed.
•When an instrument has had a shock or vibration.
•Sudden changes in weather.
•Whenever observations appear questionable.

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
Importance of Calibration
• When you regularly calibrate your instrument, you can eliminate drift in its
budding stage before it affects your measurements.
• Calibration helps in controlling errors and uncertainties to an acceptable levels.
• It helps in improving accuracy of the instrument.
• Finally in a single word, it allows pharmaceutical companies to have
confidence in their results.

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
Qualification
•It is the action of providing and documenting that equipment or ancillary
systems are properly installed, work correctly, and actually leads to the
expected results.
•Qualification is a part of validation, but the individual qualification steps
alone do not constitute process validation.
•Qualification of analytical instrumentation is essential for accurate and
precise measurement of analytical data.

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
Categories of Analytical Instruments
•Users are establishing the level of qualification needed for an instrument.
•On the basis of level, the instruments are categorized into three groups i.e., A, B,
and C.
•These categories should be determined by the user for their specific instrument or
applications.
•Depending upon the individual user requirements, the same instrument may
appropriately fall into one group for one user and another group for another user.

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
Group A :
•Group A includes standard equipment with no measurement capability or
usual requirement for calibration, where manufacturer’s specification of basic
functionality ids accepted.
•Conformance of Group A equipment with user requirement may be verified
and documented through visual observation of its operation.
•Examples of equipment in this group includes Nitrogen Evaporators,
Magnetic Stirrers, Microscopes etc.

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
Group B :
•It includes standard equipment and instruments providing measured values as
well as equipment controlling physical parameters that need calibration.
•Conformance of Group B instruments or equipment to user requirements is
determined according to the standard operating procedures for the instruments
or equipment, and documented during IQ and OQ.
•Examples of instruments are Balances, pH meters, Refractometers,
Viscometers, Thermometers etc.
•Examples of equipment are Ovens, Pumps, Water baths, Dilutors etc.

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
Group C :
•Group C includes instruments and computerized analytical systems, where user
requirements for functionality, operational, and performance limits are specific
for the analytical application.
•Conformance of this instruments to user requirement is determined by specific
function tests and performance tests.
•Installing this instruments can be complicated undertaking and may require the
assistant of specialists.
•A full qualification process should apply to this instruments.
•Examples of this type are Atomic Absorption Spectrometers, Differential
Scanning Calorimeters, Dissolution Apparatus, HPLC, Mass Spectrometers etc.

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
Phases of Qualification
•Qualification of instruments is not a single, continuous process.
•It results from many discrete activities.
•These activities have been grouped into 4 phases.
1. Design Qualification (DQ).
2. Installation Qualification (IQ).
3. Operational Qualification (OQ).
4. Performance Qualification (PQ).

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
1.Design Qualification (DQ) :
•It is the documented verification that the proposed design of facilities,
systems, and equipment is suitable for the intended purpose.
•It should be performed when new equipment is being purchased, or when
existing equipment is used for a new application.
•It also serves as a precursor for defining the equipment installation
qualification and operational qualification.

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
2.Installation Qualification (IQ) :
•Installation qualification is a documented collection of activities needed to
install an instrument in the user’s environment.
•IQ applies to a new, pre-owned or an existing onsite but not previously
qualified instrument.
•The activities and documentation associated with the IQ are as follows:
System description.
Utilities/Facility/Environment.
Network and data storage.
Assembly and verification.
Installation verification.

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
3.Operational Qualification (OQ) :
After a successful IQ the instrument is ready for OQ testing. The OQ phase
may consist of these test parameters.
•Fixed Parameters : These tests measure the instrument’s non-changing,
fixed parameters such as length, height, weight etc.
•Secure Data Storage, Backup, and Archive : When required, user may
check secured data handling, such as storage, backup, and archiving as per
the written procedures.
•Instrument Function Test : This can be done to verify that the instrument
operates as intended by the manufacturer and required by the user.

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
4.Performance Qualification (PQ) :
•After the IQ and OQ have been performed, the instrument’s continued
suitability for its intended use is proved through performance qualification.
•It includes following parameters:
1. Performance Checks:
 Set up a test or series of tests to verify an acceptable performance of the
instrument.
 PQ tests are performed routinely on a working instrument, not just only on
a new instrument.
 PQ tests are typically based on its applications at the installed place.

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
2. Preventive Maintenance and Repairs:
 When the instrument fails to meet specifications in PQ tests, it should
require maintenance or repair.
 The relevant PQ tests are also performed after its repair or maintenance.
3. SOP and Log Book:
 Establish standard operating procedure for operation, calibration, and
maintenance.
 Use a log book, binder, or electronic record to document each maintenance
and calibration activity.

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17
References
1. Bansal, Surendra & Layloff, Thomas & Bush. Qualification of analytical
instruments for use in the pharmaceutical industry: A scientific approach.
AAPS PharmSciTech. 2004; 5. E22. 10.1208/pt050122.
2. Rohit Bhatia: Calibration and Qualification of Analytical Instruments. Health
& Medicine, Slideshare, 2018.
3. Princy Agarwal: Pharmaceutical Calibration, Qualification and Validation.
Education, Slideshare, 2017.

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
Thank You