-Execution
of the PPQ protocol should not begin until the protocol has been reviewed and
approved by all appropriate departments, including the quality unit.
-Any
departures from the protocol must be made according to established procedure or
provisions in the protocol. Such departures must be justified and approved by
all appropriate departments and the quality unit before implementation.
-The
commercial manufacturing process and routine procedures must be followed during
PPQ protocol execution.
-The
PPQ lots should be manufactured under normal conditions by the personnel
routinely expected to perform each step of each unit operation in the process.
Normal
operating conditions should include the utility systems (e.g., air handling and
water purification), material, personnel, environment, and manufacturing
procedures.
-A
report documenting and assessing adherence to the written PPQ protocol should
be prepared in a timely manner after the completion of the protocol. This
report should:
Discuss
and cross-reference all aspects of the protocol.
-Summarize
data collected and analyze the data, as specified by the protocol.
-Evaluate
any unexpected observations and additional data not specified in the protocol.
-Summarize
and discuss all manufacturing nonconformances such as deviations, aberrant test
results, or other information that has bearing on the validity of the process.
-Describe
in sufficient detail any corrective actions or changes that should be made to
existing procedures and controls.
-State
a clear conclusion as to whether the data indicates the process met the
conditions established in the protocol and whether the process is considered to
be in a state of control. If not, the report should state what should be
accomplished before such a conclusion can be reached.
-This
conclusion should be based on a documented justification for the approval of
the process, and release of lots produced by it to the market in consideration
of the entire compilation of knowledge and information gained from the design
stage through the process qualification stage.
It
include all appropriate department and quality unit review and approvals.
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