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Process Validation of Ceftriaxone Sodium Dry Injection (Paperback)
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Process Validation of Ceftriaxone Sodium Dry Injection (Paperback)
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Validation is defined as the establishing of documented evidence
which provides a high degree of assurance that a planned process
will consistently perform according to the intended specified
outcomes. Validation studies are performed for analytical tests,
equipment, facility systems such as air, water, steam, and for
processes such as the manufacturing processes, cleaning,
sterilization, sterile filling, lyophilization, etc. There will be
a separate validation for the lyophilizer as an equipment item and
for the lyophilization process; for the cleaning of glassware and
the cleaning of the facility; and for the sterilization process and
for the sterility test. Every step of the process of manufacture of
a drug product must be shown to perform as intended. Validation
studies verify the system under test under the extremes expected
during the process to prove that the system remains in control.
Once the system or process has been validated, it is expected that
it remains in control, provided no changes are made. In the event
that modifications are made, or problems occur, or equipment is
replaced or relocated, revalidation is performed.
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