1. Determination of Quality Attributes
In performing
the validation, defining the quality attributes—that is, gaining a clear
understanding of the required quality and intended use—is the most important issue,
and should be determined before starting the validation. Without defining
required quality attributes we cannot establish validation protocols, which are
the basis of all validation studies.
2. The Validation Protocol
A validation
protocol is defined as
"A written plan stating how validation will be
conducted and defining acceptance criteria. For example, the protocol for a
manufacturing process identifies process equipment, critical process
parameters/operation ranges, product characteristics, sampling, and test data
to be collected, number of validation runs, and acceptable test results."
The validation
protocol is a detailed plan for conducting a validation study. It is drafted by
the individual or task group responsible for the project, reviewed for content
and completeness following the firm’s protocol review procedure, and approved
by designated individuals. It describes the responsibilities of each individual
or unit involved in the project.
All protocols,
whether for IQ (installation qualification)/OQ (operational qualification) of
new equipment or for validating a new process, have the same basic format.
They start with
an objective section, which describes the reasons for conducting the
validation study as well as the results to be achieved. Next there is a scope
section. Here what is to be included and excluded from the study is
specified, effectively establishing the boundaries for the study. Following the
objective and scope sections is a detailed description of the process/equipment
to be validated. Here block diagrams of equipment, batch formula and
master manufacturing records, process flow diagrams, and other documents
that will help with the descriptive process are essential and should be
attached to the protocol. The protocol should contain a detailed description
of the sampling and testing schedule and procedures and clearly state the
acceptance criteria for each stage of validation, such as DQ (design
qualification), IQ, OQ, and PQ (performance qualification). The number
of times that specific trials will be replaced in order to demonstrate
reproducibility of results must be specified.
The protocol
should be endorsed by designated representatives of each unit that will
participate in the validation study. This is an essential step for validation study.
It should be described that the protocol is accepted by responsible persons, and
that each unit understands and agrees to fulfill its responsibilities as stated
in the protocol. Subsequent changes to the protocol, should they be necessary,
must be endorsed by the same individuals. Protocol addenda are sometimes
necessary because circumstances later arise that were impossible to anticipate
when the study was planned and the protocol drafted. In addition to approvals,
the validation protocol should have the appended data sheets, which are to be
filled with data obtained from the validation studies and compared with the
criteria.
3. Steps of Validation
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