| Process
The FDA
defines validation as the establishment of documented evidence
that provides a high degree of assurance that a specific process
will consistently produce a product meeting its pre-determined
specifications and quality characteristics. Process
validation is essential to quality assurance because quality can
not be tested in a final product without complete destruction of
the product in most cases. Therefore, all critical
processes used to produce a final product must be adequately
designed, implemented, and controlled. Comprehensive
validation mitigates alternative in-process testing and final
product testing.
Process
validation involves the following:
- Identifying
all processes that impact the safety and effectiveness of a
final biological product to include environmental controls,
manufacturing equipment, process control, critical
utilities, and component specifications.
- Preparing
validation protocols that identify key elements of a process
and having them approved prior to the start of a study.
- Executing
sufficient numbers of replicate runs that will create test
conditions to measure upper and lower processing limits, as
well as appropriate challenge conditions.
Process
validation services include :
-
sterilization
assurance
-
endotoxin
reduction
-
cold chain
management studies
-
cleaning
validation
-
sterile
filtration
-
aseptic
filling
-
critical
utilities including water for injection, reverse osmosis
deionized water, nitrogen, and air
-
container
closures integrity studies
-
glassware,
vial , equipment washing
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