Biomedical Engineering Reference
In-Depth Information
Stakeholders who are interested but do not have information to contribute may
still be included as a means to communicate the results of the assessment. Again,
effective impact assessment relies on a sound understanding on the process,
process variables, and the effect of equipment and systems on the cause and
control of those variables.
An example of specific impact assessment questions might include the fol-
lowing:
1. Does the system come in direct physical contact with the product (e.g.,
excipients, ingredients, solvents, or processing materials or aids) at, or
after, a critical process step?
2. Does the system directly affect product quality (e.g., does the system clean,
sanitize, and sterilize or does the system maintain a classified environment)?
3. Do the system measurements directly influence or impact the product char-
acterization or impurity profile? Are they control critical process parameters
(CPPs)?
4. Does the system preserve product status? Is the system used to store and
preserve the status (e.g., preserve temperature, humidity, etc.) of interim
and final products or product sample?
5. Does the system generate data used or evaluated to support product dispo-
sition and regulatory filings?
7.3.7 Component Impact Assessments
Component impact assessments are similar to system impact assessments, but are
focused on the elements that make up the system. Component impact questions
might include the following:
1. Is the component used to demonstrate compliance with production records
requirements?
2. Does the normal operation or control of the component have a direct effect
on product quality?
3. Does failure or alarm of the component have a direct effect on product
quality?
4. Is information from this component recorded as part of the production
record, lot release data, or other cGMP-related data?
5. Does the component have direct contact with the drug product, its excipi-
ents, or device contact surfaces?
6. Does the component control critical process elements that may affect prod-
uct quality, without independent verification of the control system perfor-
mance?
7. Is the component used to create or preserve a critical system status?
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