Writing Validation Protocols

Validation
What is validation?
Relating validation and qualification

Validation is documented evidence of a process of testing,
documenting, analyzing the results, and confirming that a process
is in control. Validation provides a high degree of assurance that a
specific process, method, or system will consistently produce a
product meeting pre-determined specifications. The foundation of
this documented evidence is the validation protocol.
Qualification is the action of proving that any equipment, material,
utility, or process operates correctly. It provides assurances that
expected results will be produced. A protocol is a written
experimental plan stating how a qualification will be conducted.
Each qualification is merely a component of validation.
Validation is the sum of the installation, operational, and
performance qualifications. The testing, the results of the testing,
and the analysis of those results and the resulting documentation
are at the center of validation. Validation protocols are those
experiments that define the testing, expected results, and
acceptable standards for each of these qualifications.
INSTALLATION QUALIFICATION (IQ)
Installation qualification (IQ) is the testing of equipment to demonstrate and document

that the equipment has been installed according to the manufacturer's directions and
specifications.
An IQ protocol is an experiment or test that documents the fact that a piece of equipment
was installed according to the manufacturer's instructions. This protocol should contain
basic instructions on how to install the equipment and information about the equipment.
A basic IQ protocol involves identifying the specific piece of equipment, the model, the
steps for proper installation, and the results of documenting this installation. It defines,
demonstrates, and documents what was done.
OPERATIONAL QUALIFICATION (OQ)
Operational qualification (OQ) is the testing of a piece of equipment to prove it operates

properly over its full range of applications as specified by its manufacturer.
Like any good protocol, the OQ protocol defines, demonstrates, and documents what was
done to prove that the operation of the equipment is acceptable. This also supports that it
was installed properly.
PERFORMANCE or PROCESS QUALIFICATION (PQ)
Performance or process qualification (PQ) is used to demonstrate the performance of a

specific manufacturing process. It begins once an output or product is introduced into the
mix of equipment, materials, and people. The protocol should include information about
the equipment and materials used, process parameters, test methods, sampling, and
acceptable output. The protocol should test and establish the minimum and maximum
(i.e., the range) for the parameters of a process. It should also include acceptance or
rejection criteria, sampling information, test methods, and how the results will be
evaluated.
The PQ protocol should: define the process that is being tested; list the major equipment
involved in the testing; list the materials that will be used; lay out step-by-step
instructions for performing the test; include the acceptance criteria; and list any necessary
attachments.
VCR
Consider this situation
Because IQs, OQs, and PQs can be confusing, try applying the qualifications to
validating a VCR.
The IQ could involve testing to determine if the VCR was installed according to the
manufacturer’s instructions. It would identify the model of the VCR and the steps
involved in installing it, and document that it was installed correctly.
An OQ could involve determining how well the clock works on the VCR. The
instructions for setting the clock would be followed and the time set. The time on the
VCR could then be compared against a stopwatch to make sure that it is keeping proper
time.
The PQ could involve demonstrating the recording function of the VCR. Testing the
ability of the VCR to record a television program and evaluating the quality of the
recording, such as how clear the playback is and whether there’s any static or low sound
quality, is a good example of a performance or process qualification.
Keeping the protocols straight

A good way to differentiate between the three types of qualification protocols is to
remember that IQ and OQ protocols are written when dealing primarily with the testing
of equipment. A PQ protocol should be written when a process needs to be tested.
Format
What is the basic format of a protocol?
Essentials of a good protocol

There are four essentials of a good protocol used to create a basic protocol format. Click
on each dot in the image below to learn more about these essentials.
Team Authorship
When preparing to write a validation protocol, include input from key areas. Gather
"experts" on equipment, materials, processes, and products and have them write on their
respective areas to ensure that all critical aspects will be covered.
Clear Definition
Clearly state and define exactly what is being validated. Be sure to make it clear where
the process you are validating begins and ends. Since the protocol is designed to test
specific things, there is no place for the undefined.
Simplicity
Limit the scope of the protocol to only the information that is necessary in the proper
execution of the protocol. Extra information can often lead to confusion.
Flexibility
Flexibility provides a means for the protocol to be changed and modified. You should be
able to do this with the least amount of difficulty and complexity. Ensure that the needed
changes are controlled and approved.
Titles
The title of the protocol is more important than one would think. The title sets the
boundaries and identifies what is being validated. Everything else that follows in the
protocol is intimately related to the validation. For example, a protocol entitled
“Validation of Bar Code Readers” gives clear information about the process, materials,
and equipment that will be involved in the validation.
Elements
What should be included in a validation protocol?
State a clear purpose
The purpose is a statement about the rationale (why and what) of the validation. Stating
why you are validating a piece of equipment or a particular process helps to work out the
details of the protocol. If you start with a purpose, you can work through the details, from
beginning to end. This includes determining which type of qualification protocol to use.
Choose the right sampling and testing plan
Consider many questions during this stage: How long must the process be run to ensure
that it is representative? What sampling plan will be used and on what logic is it based?
What test methods will be used and are they appropriate? How many examples should
you look at (sampling) and how should you evaluate what you see (testing)?
Clearly define the equipment or process being validated
Clearly defining the process or operation will let everyone know what the boundaries are
and what is involved. This step is often called the system or process description and
includes diagrams, flow charts, or other tools to ensure that the process or operation is
clearly defined.
Determine acceptance and rejection criteria
Acceptance or rejection criteria are the attributes that demonstrate good/bad output from
the process or operation. These are methods for evaluating results from the execution of
the protocol. The criteria should be determined in advance and be stated in the protocol.
The results from testing must be reported and compared with the criteria.
Identify major equipment involved and materials used
Identify all the major pieces of equipment involved in the process or operation being
validated. List all the materials used in the process or operation. Give as much detail
about the equipment and materials as possible.
Identify process parameters and ranges
Every manufacturing process has its controls (parameters) and limits (ranges). Identify
the parameters that control the process, such as speed, time, and temperature. The ranges
are the highs and lows of the controlling parameters under acceptable operating
conditions.
Provide for review and approval
All good protocols provide for a comprehensive review and approval. Reviewers and
approvers must understand what they are reviewing and approving. List all individuals
who must approve the protocol before it can be executed. Just as a protocol should be
written by a team, it should also be reviewed and approved by a team.
Provision for addressing deviation
Departure from the established protocol must be made according to established procedure
or provision in the protocol. Such departures must be justified and approved by all
appropriate departments and the quality unit before implementation.
Final validation report
One of the key documents in validation is the final validation report. It is the executed
protocol and the results of that execution that form the basis of the report. The foundation
of this report is the protocol. A faulty protocol leads to a faulty report.

Writing Validation Protocols

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Validation

Relating validation and qualification

INSTALLATION QUALIFICATION (IQ)

Installation qualification (IQ) is the testing of equipment to demonstrate and document

OPERATIONAL QUALIFICATION (OQ)

Operational qualification (OQ) is the testing of a piece of equipment to prove it operates

PERFORMANCE or PROCESS QUALIFICATION (PQ)

Performance or process qualification (PQ) is used to demonstrate the performance of a

Keeping the protocols straight

Essentials of a good protocol

State a clear purpose

Choose the right sampling and testing plan

Clearly define the equipment or process being validated

Determine acceptance and rejection criteria

Identify major equipment involved and materials used

Identify process parameters and ranges

Provide for review and approval

Provision for addressing deviation

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