VALIDATION

DOCUMENTATION

Complete documentation of all specifications,

Procedure (SOP’s), Protocol, Activities, Data record
system, validation documentation, certification and
record evaluation.

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EQUIPMENT

Appropriate design, Capacity matching with batch

size / work load, Sufficient in number for optimum
utilization, Effectively validated, calibrated and
maintained.

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S Gupta 37
• Validation
• Calibration
• Environment Control
• Document Control
• Change Control
• Quality Control

QUALITY ASSURANCE
What is Validation ?

Documented proof that everything, within

reasonable certainty, that is involved in the
manufacture of a product is under control.
This includes the facility, the environment, the
materials, the equipment and the processes
including manufacture and cleaning procedures.
WHY VALIDATION

To Establish by documented Evidence

to provide a high degree of assurance
that a planned process will consistently
perform according to the intended
specified outcomes
MASTER VALIDATION PLAN

It is a document pertaining to the

“whole facility” that describes which
Equipment. Systems. Methods and
Processes will be validated and when
they will be validated.
It also includes Re-Validation- why and
when
Types of Validation

Prospective Validation

Validation conducted before

manufacturing a new product or
manufacturing a product after
making changes in the process which
can have a gearing on the products
quality
Types of Validation..contd.

B. Retrospective Validation

Validation of a process already in

production based upon accumulated
production, testing & control data, i.e., past
records in the possession of the manufacturer
VALIDATION CONSISTS OF

Design Qualification - DQ

Installation Qualification - IQ

Operational Qualification - OQ

Performance Qualification - PQ
DESIGN QUALIFICATION

Necessary when planning and choosing

equipment or systems to ensure that
components selected will have adequate
capacity to function for the intended
purpose.
Example- selection of steam generator.
Master Validation Plan must address
sequence of DQ.
INSTALLATION QUALIFICATION

Qualification of a piece of equipment

should check for the requirements that
are mentioned in the DQ
Compare with the purchasing information
and invoice data
Requirements- Name, description, model,
identification numbers, location, utility
requirements, connections, safety
measures 0f the system
 IQ - continued
During Installation Qualification it
should be verified that the following
matches the purchase specification:
Drawings,
manuals,
spare parts list,
vendor address and contact
number,
Other pertinent documentation.
 Simple Example of
Installation Qualification

1. Equipment: _________________

2. Model: _________________

3. Manufacturer: _________________

4. Date of Purchase: _________________

5. Date of Installation _________________

6. Calibration done by _________________

1. Manual Provided/Not Provided Remarks

2. Physical Damage OK/Damage found

3. Dimensions Not / As per

requirement
4. Switches OK/Damage/Inadequate

5. Covers Working OK/Damage/Inadequate

6. Limit Switches OK/Damage/Inadequate

7. Electrical OK/Damage/Inadequate
Fittings
8. All fastenings OK/Damage/Inadequate
The details of the equipment should be
critically tallied with the order placed with the
vendor. Needless to add the order placed
should be as per the Design Qualification
(DQ). All critical components of the
equipment should be tabulated and only after
successful verification should the equipment
verified as conforming to IQ
OPERATIONAL QUALIFICATIONS

Outlines the information required to provide

evidence that all the components of a system or
equipment operate as specified.
 OPERATIONAL
QUALIFICATIONS…contd.
This involves testing of all:
normal operation controls,
all alarm points,
all switches,
all displays,
interacting controls,
any other indications of operation &
functions
 OQ - c o n t i n u e d

Specifications and acceptance criteria

must be defined for all operation

Should provide a listing of SOPs,

reference to specific manual
instructions for operation, maintenance
and calibration
Simple Example of
Operational Qualification

Equipment: _________________
Model: _________________
Manufacturer: _________________
Date of Purchase: _________________
Date of Installation _________________
Calibration done by _________________
List of Calibrating Equipment & Instrument
(enter list of all instruments used for
calibration along with details of the
instruments)
 Simple Example of
Operational Qualification
contd.
• Documents required
(enter list of all documents used for the calibration)

Calibration Record
Sl. No. Control/Alarm Calibrated by Result Remarks
 Simple Example of
Operational Qualification
Contd.
Control & Check Parameters
Sl. No. Parameters Range Observation Deviation Remarks

Results & Conclusion

Signature
Performance Qualification

To be carried out after both IQ and OQ have

been successfully completed

Describes the procedures for demonstrating

that a system or piece of equipment can
consistently perform and meet required
specifications under routine operation, and
where appropriate, under worst case
situations.
 PQ - c o n t I n u e d

Describe the preliminary procedure

required
Detailed performance test
acceptance criteria for each test
all supporting systems and procedures
should have been validated (e.g.. Steam
system should be validated before
autoclave validation)
 Process Validation

Performance (How to do it)

Process : Run the process according to SOP three

times and record all required data.
Deviations to the procedures must be recorded on
the data record forms.

Analytical tests: Perform the routine tests

associated with the process according to SOP, Test
results must be approved by the QC.
 Evaluation

Attach all data record forms and charts.

Perform all calculations and analyses
which are predetermined and approved.
Compare with the accepted criteria.
 Prepare Deviation Report

Deviation if any must be recorded

and justification for acceptance, if
any, mentioned.
 Prepare Process Validation Report

This must mention start date, completion date,

observations, problems encountered,
completeness of information, summary of the
deviation report, results of test, comparison
with the accepted criteria, other relevant data.
Conclusion should take into account individual
as well as the results of three consecutive
validation runs.
 Approval and Acceptance

QA should review and approve the report.

The Process must meet all specifications
For three consecutive runs
 Process Validation
Requirements
Type of process Validation Requirements

New Every new process must be validated

before approval for routine production

Existing All processes affecting sterility and

1. Process designed to render a
product sterile
2. Non- sterile production
manufacturing environment must be
validated; the most important is the
sterilization stage.
Low-dose tablets and capsules containing
highly active substances: validation of
mixing and granulation in relation to
content uniformity.
Other tablets and capsules: Validation of
tablet compressing and capsule filling in
relation to uniformity of mass.
Example of Process Validation
Manufacture of Paracetamol tablets
Procedure of receipt of RM to the plant
Procedure of storage and testing
Procedure of issue of material to Prod.
Actual manufacturing:
Weighing
Sieving
mixing
Granulation
Drying
Example of Process Validation

Lubrication
Compression

Release & Packing

Each of the above operations have to be

validated against the requirements of the
procedure and documented!!!!
Thanks