-A written protocol that specifies the
manufacturing conditions, controls, testing, and expected outcomes is essential
for this stage of process validation. We recommend that the protocol discuss
the following elements:
-The manufacturing conditions, including
operating parameters, processing limits, and component (raw material) inputs.
-the data to be collected and when and how it
will be evaluated.
-Tests to be performed (in-process, release,
characterization) and acceptance criteria for each significant processing step.
-The
sampling plan, including sampling points, number of samples, and the frequency
of sampling for each unit operation and attribute. The number of samples should
be adequate to provide sufficient statistical confidence of quality both within
a batch and between batches.
-The
confidence level selected can be based on risk analysis as it relates to the
particular attribute under examination. Sampling during this stage should be
more extensive than is typical during routine production.
-Criteria
and process performance indicators that allow for a science- and risk-based
decision about the ability of the process to consistently produce quality
products. The criteria should include:
-A
description of the statistical methods to be used in analyzing all collected
data (e.g., statistical metrics defining both intra-batch and inter-batch
variability).
-Provision
for addressing deviations from expected conditions and handling of
nonconforming data. Data should not be excluded from further consideration in
terms of PPQ without a documented, science-based justification.
-Design
of facilities and the qualification of utilities and equipment, personnel
training and qualification, and verification of material sources (components
and container/closures), if not previously accomplished.
-Status
of the validation of analytical methods used in measuring the process,
in-process materials, and the product.
-Review
and approval of the protocol by appropriate departments and the quality unit.
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