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Miss Shraddha Kulkarni

Dept. of Pharmaceutics.
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Contents:
1. Introduction.
2. Definition.
3. Importance of Validation.
4. Advantages of validation.
5. Scope of Validation.
6. Validation of Equipments.
-Stages of equipment qualification.
-Assembling of a validation protocol.
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I ntroduction:
Validation means rectification or confirmation.
It is the concept which establishes a documented program of specified & reliable
performance.

Definition:
According to U.S.F.D.A.,
Validation is a documented progamme, which provides a high degree of
assurance that a specific process will consistently produce, a product meeting
its pre-determined specifications & quality attributes.
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I mportance of Validation:
Every activity in business unit is done to get some benefits from that & naturally
Pharmaceutical Validation is no exception.
This means validation activity must give the industry some advantages/ some
benefits.
Four major advantages of validation:
1. Reduction of quality costs.
2. Process optimization.
3. Assurance of quality.
4. Safety.
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Validated &
controlled processes
produce quality
products
consistently.
Increase in
operation safety.
Making the process
effective, efficient,
perfect or useful at
minimum cost.
Preventive costs
Appraisal costs
Internal failure cost
External failure cost.
Reduction
of quality
cost
Process
optimization
Assurance of
quality
Safety
Advantages of Validation
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Scope of Validation:
Pharmaceutical validation is a vast area of work & it covers almost every aspect of
pceutical processing activities, e.g.,
Analytical
test method.
Facilities
Instrument
calibration
Mfg
operation
Process
utility
services
Product
design
Raw
materials
Cleaning
Packaging
materials
Operators
Equipment
Scope
Of
Validation
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Validation of Equipments:
The basic component of pharma industry are the Equipments.
Therefore before validating a process that is carried out in a pharma industry,
the issue of equipment validation becomes a prime importance.
Equipment validation is covered in several steps:
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1. User requirement specifications/ customer requirements(USR)
2. Design Qualification(DQ)
3. Installation Qualification(IQ)
4. Operational Qualification(OQ)
5. Performance Qualification(PQ)

Principle
Equipment must be
located
designed
constructed
adapted
maintained
to suit the operations to be carried out.
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Equipment layout and design must aim:
to minimize risks of error.
to permit effective cleaning and maintenance.
To avoid:
1. cross-contamination, dust and dirt build-up.
2. any adverse effect on the quality of products.

Equipment must be installed to:
1. minimize risks of error.
2. minimize risks of contamination.
Control laboratory equipment-
Equipment and instruments-
suitable for the tests to be performed.
Defective equipment-
Removed.
Labelled.

Washing, cleaning and drying-
Equipment used for washing and drying not the source of contamination.
Equipment design should promote easy cleaning.
Cleaning on scheduled basis, procedures and records.

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Qualification policy for systems and equipment-
To include instruments used in production and quality control.
New systems and equipment:
All stages of qualification applicable (DQ, IQ, OQ and PQ).
Qualification should be done in accordance with predetermined and
approved qualification protocols.
The results of the qualification should be recorded and reflected in
qualification reports.
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A) User requirement specifications:
What are the expectations of the customer?
General requirements may be stated as follows:
1. size of the equipment
2. Speed of the equipment
3. Effectiveness of the equipment
4. Availability of the spares, change parts, prompt services at reasonable
cost.
5. Ease of operation, cleaning & maintenance.
6. Low dust & sound generation.
7. Lesser breakdowns.
8. Overall good construction & workmanship.
2. Preparation of Design qualification-
o User requirements should be considered when deciding on the specific
design of a system or equipment.
o A suitable supplier should be selected for the appropriate system or
equipment(approved vendor).
o For purchasing a standard equipment, it is not essential to prepare a D.Q.
document.
o If the user asks for a specialized type of instrument, then he must submit his
Requirements in the form of a detailed design qualification document to the
supplier.
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3. I nstallation qualification-
Verifies that the correct equipment has been received and installed as per
plan and protocol. Also that it is complete and undamaged (parts, services,
controls, gauges and other components).
Verifies that equipment has been properly installed and calibrated
including connections to utilities.
Documented records for the installation
I nstallation qualification report.
Include details, e.g.
The supplier and manufacturer.
System or equipment name, model and serial number.
Date of installation.
Spare parts, relevant procedures and certificates.
4. Operational qualification:
Systems and equipment should operate correctly operation verified as in
the qualification protocol.
Verifies that the equipment operates consistently within established limits
and tolerances over the defined operating ranges.
Challenges equipment functionally to verify compliance with
manufacturers specifications and end user defined requirements.
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Documented records -
(Operational qualification report)
Finalize and approve SOP (operation)
Training of operators provided training records.
Systems and equipment released for routine use after completion of
operational qualification, provided that:
All calibration, cleaning, maintenance, training and related tests and
results were found to be acceptable.
5. Performance qualification:
Verifies that the equipment performs according to design specifications and
user defined requirements in a reliable and reproducible manner under
normal production conditions.
Verified in accordance with a performance qualification protocol.
Documented records
performance qualification report
Show satisfactory performance over a period of time, i.e. carried out long
enough to prove that the equipment is under control and turns out product
of specified quality consistently.
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Assembling of a validation protocol:
Documented formats or protocols.
Helps in systematizing the study of equipment validation.
Different formats have been specified for designing protocols & carrying out IQ,
OQ & PQ.
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Purpose:
This procedure details the assembly & contents of the validation protocol for use
in validation testing.

Principle:
This protocol is generated by a validation specialist/engineer.
Protocol section contains required forms & procedures.
Procedure describes how the system is to be validated while
Forms document these procedures & provide a written record of the executed
qualification & validation processes.
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Testing procedures: Protocol packages are divided as

OQ PQ IQ
SECTIONS OF A STANDARDISED PROTOCOL:
Table of contents
List of standard sections.
Unique testing procedures.
Approval page
Pre-approval section.
Final approval section.
Description
Statement of purpose.
Standard operating procedures.
(correct, complete & most current versions)
Calibration.
Utilities.
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Purpose:
This procedure describes the testing sections of an installation qualifications for a
piece of an equipment.

Principle:
It includes the sections of the standardized protocol.
A general description of the approaches & rationale to be used when writing the
Inspection & Installation sections of this protocol.

Procedure:
Inspection checklist.
Installation checklist.
A. Installation qualification- Equipment:
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I . I nspection checklist:
Instruction explains how this section is physically executed.
Table of Contents lists the major components of an equipment.
Specified Explains manufacturers specifications.
Actual The things that are actually observed they are
listed here.
Two approaches are commonly employed:
1. Like components
2. Order of sequence
Like components of the system may be grouped in the Table of contents, but
their individual characteristics will be listed out separately.
Order of sequences starts with the component which begins the process & then
proceeds through the system.
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II. Installation checklist:
This section of protocol determines whether or not a piece of the equipment or
system as a whole meets the manufacturers design specifications.
It is recorded as yes or no.
Any no's are then recorded as deviations or deficiencies.

Environmental requirements:
Specifically considers humidity, temperature, of a particular piece of the
equipment.
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B. Operational qualification:
Purpose:
It defines the procedure for the operational qualification of a piece of equipment.

Principle:
After installation, the verification of equipment capability is performed.
Includes:
Alarm testing, control system testing, operation & maintenance procedures.

Test equipments:
List the necessary test instruments, before starting the test, first the instrument is
to be Calibrated & maintained as such till the completion of the test.
Test procedure:
e.g. alarm testing, Operation testing.
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C. Performance qualification:
Purpose:
To define testing requirements in a product/ process/ performance qualification/
validation protocol.

Principle:
This gives a general outline of the issues related to the process or plan.
Includes:
Background & reason for the plan.
Testing method used.
Predetermined general /specific acceptance criteria.

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Test equipment:
List any test instrument necessary & must be calibrated prior to use & till the
process completes.
Procedure:
This is the final phase of the validation process.
Before PQ validation testing is implemented for all processes
Product specifications are established
& judged acceptable.
Testing procedures:
Design of the expt.
These procedures are tailored to challenge the exact process or product to be
validated using normal operating parameters in a SOP
Validation will demonstrate that by using these parameters the quality product
intended can be produced consistently.
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Worst case conditions:
A worst case challenge will encompass upper & lower process limits &
circumstances & will pose greatest chance of process or product failure when
compared to actual production conditions.

Microbiological challenges:
Controlled environment is necessary for the production of many pharmaceutical
products & sterile environments is essential for the manufacture of parenterals.
For a predetermined period of time test for microbial growth is performed under
certain challenge condition.
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Conclusion:
User requirement specifications play an important role in the design of an
equipment.
In order to design a specialized instrument a design qualification document is to
be submitted by the customer to the supplier.
When an equipment passes all the norms that are specified in an I.Q., O.Q. &
P.Q. test, the equipment is said to be validated.
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References:
1. Pharmaceutical Quality Assurance
by Manohar A. Potdar.
Nirali Prakashan
Page no- 8.1 to 8.22

2. Equipment & Its Qualification
By Rutendo Kuwana
Technical Officer, WHO, Geneva.
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Thank you