Calibration and Validation

1. 4.8.7 T QUALITY ASSURANCE
TECHNIQUES
SAVITRIBAI PHULE PUNE UNIVERSITY
Syllabus of Final Year B. Pharmacy
(EFFECTIVE FROM ACADEMIC YEAR 2018-19)
PATTERN 2015

2. Hello!
I am Shrikant Kavitake
M Pharm (Pharmaceutics)
DATTAKALA COLLEGE OF PHARMACY
Swami-Chincholi, Daund, Pune.
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3. 2.
Calibration &
Qualifications
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 Qualification
 Qualification types
 User Requirement
Specifications
 Calibration
 Methods
 Purpose
 Frequency
 Importance
 Calibration of
Dissolution Test
Apparatus & pH
meter

4. ‘’
Definition;
 Qualification
Qualification is defined as action of proving and
documenting that equipment are properly
installed, work correctly, and actually lead to
the expected results. Qualification is part of
validation, but the individual qualification steps
alone do not constitute process validation.
It is divided into following types
1. Design Qualification (DQ)
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)
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5. Qualification includes the following
steps:
1. Design qualification (DQ)- Demonstrates that the proposed
design will satisfy all the requirements that are defined and
detailed in the User Requirements Specification (URS).
Satisfactory execution of the DQ is a mandatory requirement
before construction (or procurement) of the new design can
be authorised.
▣ Purpose: To ensure that all the requirements for the final
system have been clearly defined at the start.
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6. Cont…
2. Installation qualification (IQ) – Demonstrates that the
process or equipment meets all specifications, is installed
correctly, and all required components and documentation
needed for continued operation are installed and in place.
▣ Purpose: To check the installation site/ environment & verifies
the condition of installed equipment. Also to ensure that all
aspect of equipment installed correctly and complies with
the original design.
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7. Cont…
3. Operational qualification (OQ) – Demonstrates that all
functions of the process or equipment are operating
correctly.
▣ Purpose: To ensure that all the dynamic attributes
comply with original design.
4. Performance qualification (PQ) – Demonstrates that the
process or equipment performs as intended in a
consistent manner over time.
▣ Purpose: It is ensure that the instrument is performing
within specified limits.
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8. User Requirements Specification
(URS).
 The User Requirements Specification describes the
business needs for what users require from the system.
 User Requirements Specifications are written early in the
validation process, typically before the system is created.
They are written by the system owner and end-users, with
input from Quality Assurance.
 Requirements outlined in the URS are usually tested in the
Performance Qualification or User Acceptance Testing.
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9. Cont…
 User Requirements Specifications are not intended to be a
technical document; readers with only a general
knowledge of the system should be able to understand the
requirements outlined in the URS.
 A URS defines clearly and precisely, what the customer (i.e.
you) wants the system to do, and should be understood by
both the customer and the instrument vendor.
 The URS is a living document, and must be kept updated,
via a change control procedure.
 This focuses on the ‘‘what’’ rather than the ‘‘how.’’
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10. Cont…
A well-written URS provides several specific benefits, as it:
▣ Serves as a reference against which off-the-shelf
commercial products are selected, evaluated in detail, and
any enhancements are defined.
▣ Reduces the total system effort and costs, since careful
review of the document should reveal omissions,
misunderstandings and/or inconsistencies in the
specification and this means that they can be corrected
easily before you purchase the system
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11. Calibration
Definition: Calibration is a process where a comparison is
made between two entities, one whose value has to be
measured and the other entity, known as the standard, which
is used as the reference in the comparison.
 Methods for calibration:
1. Standard Calibration
2. Calibration with Data
3. ISO 17025 Accredited Calibration
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12. Methods used for calibration:
1.Standard Calibration: This method is mostly preferred for
calibrating instrument that are non-critical to quality or not
required for accreditation and license purposes
2. Calibration With Data: Procedure for calibration with data
are similar to that of accredited calibration. Only exception
being that these procedure are not accredited to the ISO
standard. Moreover, they not accompanied by data on
measurement uncertainties.
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13. Cont…
3. ISO 17025 Accredited Calibration: This has to be a
strictest method of calibration. Generally it requires a
measurement reports which has the details of the
measurement that are maid against the standard of
"as found" (before calibration is started) & "as left" (once
the calibration is completed). If the calibration is done
bye service provider they must issue a certificate of the
same.
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14. Scope/ Purpose of calibration:
 Calibration can be perform for the following purpose:
1. To make sure that the readings of equipment or
instruments are consistent with other measurements
and display the correct readings every single time.
2. To determine the accuracy, precision, reliability and
deviation of the measurements produced by all the
instruments.
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15. Cont…
 Accuracy: Closeness to the test results obtained by that
method to the true value.
 Precision: Degree of agreement among individual results when
the method is applied repeatedly to multiple sampling of a
homogeneous sample.
 Reliability: Degree to which an assessment tool produce stable
& consistent result under the same condition.
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16. Cont…
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Deviation: Is a measured difference between observed value
& expected or std. value for a process or product.
▣ To establish the reliability of the instrument being used
and whether it can be trusted to deliver repeatable results
each time.
▣ To map the ‘drift’ as documented. Instruments have a
tendency to produce inaccurate measurements over a
period of time, following repeated use.

17. Frequency of calibration:
Calibration interval may be based on calendar.
The frequency of calibration depends on following factors:
a) What is level of accuracy desired?
b) What is the recommendation of manufacturer?
The interval between calibration varies as:
a) Weakly
b) Monthly or bi-monthly
c) Annually or semi-annually
d) After every heavy usage of equipment or instrument.
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18. Importance of calibration:
 Calibration is responsible for defining the accuracy of any
measurement and its quality that is recorded by any
instrument.
▣ Regularly calibration of any equipment can eliminate the
draft at its building stage instead of allowing it to grow till it
affects the measurement in significant ways.
▣ Calibration helps in quantifying and controlling errors and
uncertainties within various measurement process to an
acceptable level.
▣ Further, it helps in improving the accuracy of the measuring
device, which in turn improves the quality of the FPP. 18

19. Cont…
 In short regular calibration allows pharmaceutical
companies to have confidence in there result which
they can record monitor and control.
 Calibration are not optional but needed for regulatory
compliance.
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20. Thanks!
Any questions?
You can find me at
kavitakeshrikant@gmail.com
Kavitakes.dkcop@dattakala.edu.in
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