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1. Presented by Dinesh kumar
M.pharma(Pharmaceutics)
University school of Pharmaceutical Sciences

2. Content
 Introduction
 Scope of validation
 Importance of validation
 ICH & WHO guidelines for calibration and validation of
equipments
 Validation and calibration master plan
 Validation of specific dosage form
 Types of validation
 Government regulation, manufacturing process model
DQ,IQ,OQ and PQ of facilities

3.  Validation is an important part of pharmaceutical industry to
establishing documented evidence that provides a high
degree of assurance that a process , system, equipment or
assay will consistently produce the desired results according
to predetermined specification and quality attributes.
 The documented action of showing that any equipment work
correctly or not and to show the expected result.

4. 1. Selection of raw material i e raw material of desired quality
2. Product design based on the expected performance
3. In process quality control parameters and sampling plans.
4. Finished product testing.
5. Validation of related system and equipment are used
6. Validation of related analytical process.

5. 1.It help to determine the risks that may arise during the
manufacturing of the quality products
2. Deep study and understanding of the system and equipment
are made possible due to the validation
3. Validation helps to investigate the derivations caused during
the process
4. Reduce product cost
5. Decrease the chances of failure of the batches

6. WHO guidelines for validation:
1. All equipments and other devices used to measure the
physical properties of substances must be regularly
calibrated, validation and verified.
2. Specific procedures must be established for each type of
equipment, instrument and other device, having regard
to extent to which they are used, verified and calibrated
at regular intervals according to SOP.
For example:
 ph meters are verified with standard certified buffer
solution
 infrared spectrophotometers require verification and
calibration at regular intervals.

7. 3. Only authorized person should operate equipment, instrument and
devices. Up- to- date instruction must be there.
4. Each item of equipment, instrument or other devices used for
testing, verification and calibration must, when practicable, be
uniquely identified.

8. Theses are mainly use to maintain the safety Efficacy and quality.
 Quality
 Efficacy
 Safety
 Quality : Those relating to chemical and pharmaceutical
Quality Assurance (Stability Testing, impurity testing etc).
 Efficacy: Those relating to clinical studies in human subject
(Dose response Studies, Good Clinical Practices, etc).
 Safety: Those Relating to in vitro and in vivo pre- clinical
practices (Genotoxicity testing etc)

9. 1.Validation master plan : VMP discuss validation all activities.
An approved written plan of objectives and actions starting
how and when a company will achieve compliance with the
GMP requirements regarding validation. VMP is a summary
intention document starting the scope of the validation and
outlining the methods to be used to establish the performance
adequacy.
The validation master plan should provide an overview of the
entire validation operation, its organization structure, its
content and planning.
(a). Process Validation
(b). Cleaning validation

10. (c). Documented validation
(d). Qualification validation
(a). Process validation: Process validation is collection and
evaluation of data from the process design stage through
commercial production, which establish scientific evidence
that a process is capable of consistently delivering quality
product.
1. Prospective validation
2. Concurrent validation
3.Revalidation validation

11. 1. Prospective validation: It is establishing documented
evidence prior to process implementation that a system it is
based on preplanned protocols.
• This approach to validation is normally undertaken
whenever the process for new formula must be validated
before routine pharmaceutical production commences.
• This is include initial stages of equipment validation.
2. Concurrent validation: It is establishing documented
evidence that is based on information generated during
actual implementation of the process
 Revalidation due to changes e.g increase batch size

12. 3. Retrospective validation: Repeating the original validation
effort or any part of it, and includes investigative review
existing performance data. The revalidation process includes:
 The transfer of product from one plant another
 Change to the product, the plant, the manufacturing process,
the cleaning process etc.
(b) Cleaning validation: It is use to assure that a cleaning
process remove chemicals and residues of active, inactive or
detergent ingredients of product manufacturing in piece of
equipment.
 When we talk about cleanliness and cleaning
validation, we mainly refer to equipment.

13. (c). Documented validation: Purchase drawings
 Engineering drawings
 MOC certificate
 Test certificates
 Operating manuals
 Safety instruction
 Qualification protocols
(d) Qualification validation: 2 type
1. Design qualification
2. Installation qualification

14. 1. Design qualification: : Before purchasing a new instrument.
2. Installation qualification: installation (such as machine,
computer system component, measuring devices, utilities and
manufacturing areas) used in processor systems

15. • It is based on the comparison of a primary standard or
instrument of known accuracy with another equipment to be
calibrated.
• It is use to detect, correlates report or eliminate by adjustment
of any variation in the accuracy of the equipment being
calibration.
• Accuracy
• Precision
• Specificity
• Detection limit
• Accuracy: minimum of 3 range are determined
• Precision: measure the accuracy

16. Validation protocol for tablet
Tablet is solid dosage form how process will be conducted
define testing parameters, sampling plans testing method and
specification will specify product characteristics and
equipment to be used.

17. Granulation: it is process of collecting particles by creating
bonds between them. It involve in tablet manufacturing like
hardness, disintegration and dissolution etc depend upon
granulation parameters.
Drying: It is use to drying the wet mass granules having
moisture content is present. the instrument use in drying in
Hot air oven.
Blending: It involve mixing of granules with other blending
materials to impact good flow and anti adhesive property to
the blend increase in disintegration time due to coating of the
granules with low melting lubricants like

18.  Compression: The major variable affecting the
compression process are machine speed and
compression force needs to be controlled as it effects
the tablet harness, thickness and disintegration time
And dissolution rate.
 Blister packing: This process involves packing in
polyethylene lines aluminum and PVC blister pack

19. (a) Process validation
(b) Cleaning validation
(c) Equipment validation
(d) Analytical method validation
(a). Process validation: Process validation is collection and
evaluation of data from the process design stage
through commercial production, which establish
scientific evidence that a process is capable of
consistently delivering quality product.
 1. Prospective validation
 2. Concurrent validation

20.  2. Concurrent validation
 3.Revalidation validation
1. Prospective validation: It is establishing documented
evidence prior to process implementation that a system
it is based on preplanned protocols.
 This approach to validation is normally undertaken
whenever the process for new formula must be
validated before routine pharmaceutical production
commences.
 This is include initial stages of equipment validation.
2. . Concurrent validation: It is establishing documented
evidence that is based on information generated during
actual implementation of the process
 Revalidation due to changes e.g increase batch size

21. 3. Retrospective validation: Repeating the original validation effort or any
part of it, and includes investigative review existing performance data. The
revalidation process includes.
(b) Cleaning validation: It is use to assure that a cleaning process remove
chemicals and residues of active, inactive or detergent ingredients of
product manufacturing in piece of equipment.
(c) Equipment Validation: 1. Design Qualification: Before purchasing a
new instrument.
2. Installation Qualification: At documented installation of new or existing
instrument.
3.Operational Qualification : After installation
 After major changes e.g. repair, updates
 At regular intervals (risk based)
4. Performance Qualification : Whenever the instrument is used e.g. daily.

22. (d)Analytical method validation: To analyze the material by the use of
analytical procedure.
• Validation of analytical methods is an essential but time-
consuming for most analytical development laboratories.
• All analytical method that are intended to be used for
analyzing and clinical samples will need to be validated.

23.  DQ (Design qualification): It is the process of
completing and documenting design reviews to all
quality aspects have been fully considered at the
design stage. The purpose is to ensure that all
requirements for the final systems have been clearly
defined at the start.
Design Qualification defines the functional and
operational specifications of the instrument and details
the conscious decisions made in the selection of the
supplier. DQ should ensure that instruments have all
the necessary functions and performance criteria that
will enable them to be successfully implemented for

24.  the intended application and to meet user
requirements.
2. IQ (INSTALLATION QUALIFICATION): ):
Installation qualification is the process of checking the
installation, to ensure that the components meet the
approved specification and are installed correctly, and
to see how that information is recorded.
Installation qualification establishes that the instrument is
received as designed and specified, that it is properly
installed in the selection environment, and that this
environment is suitable for the operation and use of the
instrument.

25. Before installation:
 Check the site for the fulfillment of the manufacturer’s
recommendations (utilities as electricity, water and
gases plus environmental conditions such as humidity,
temperature, validation level and dust).
 Allow sufficient shelf space for the equipment itself,
related SOPs, operating manuals, logbooks and
software.

26. 3.OQ (OPERATIONAL QUALIFICATION): OQ is the
process of testing to ensure that the individual and
combined systems function to meet agreed
performance criteria and to check how the result of
testing is recorded. The purpose is to ensure that all the
dynamic attributes comply with the original design.
• Each of the instrument’s function are checked to
ensure that they conform to manufacture’s
specifications.
• This includes the use of certified, traceable electrical
simulators and standards to verify that the equipment
is processing input signals correctly.

27. 4. PQ (PERFORMANCE QUALIFICATION)
 PQ is also called process qualification, is the process of
testing to ensure that the individual and combined
systems function to meet agreed performance criteria
on a consistent basis and to check how the result of
testing is recorded. The purpose is to ensure that the
criteria specified can be achieved on a reliable basis
over a period of time.
 The performance of the equipment for its routine
analytical use is checked to ensure that this
complies with its specification.

28. Question (Long question)
1. What is validation and its scope or importance.
2. What is validation and explain its master plan.
3. What is validation and explain its different type.
4. Explain IQ, OQ, PQ.
Short question
1. Explain scope of validation.
2. Type of validation.

29.  THANK YOU