Biomedical Engineering Reference
In-Depth Information
• relevant clinical trial protocols and randomization codes, as appropriate;
• relevant technical agreements with contract givers, as appropriate;
• stability data; and
• storage and shipment conditions.
It is important to retain company memory of the development process. The devel-
opment history should be captured in a development report or the equivalent
of the medical devices quality system requirement (QSR)s Design History File
(see Reference 8). This report should provide an audit trail of manufacturing
instructions and analytical methods development including changes and showing
comparability from preclinical through commercialization. This should be a life
cycle document that is updated regularly, including after commercialization, as
additional knowledge of product and process is gained. FDA's Process Valida-
tion Guidance describes the first stage of validation as process design. If the
history file/development report is carefully constructed with reference to small-
scale experiments, pilot batches, and scale-up through technology transfer, it may
meet the requirements for the first stage of validation. To that end, it would be
appropriate to write a protocol for data collection and analysis toward the later
stages of product and process development. The following points could be added
to the list of items to be identified in the product specification file:
• quality target product profile;
• list of (critical) process parameters;
• list of (critical) quality attributes;
• product control strategy;
• drug product development report;
• analytical method development report;
• review of comparability of batches from preclinical through human trials
for comparability;
• risk assessments;
• risk communication documentation; and
• risk review (including corrective and preventive actions (CAPA) and feed-
back).
Each of the documents in the product specification file will be controlled and
earlier versions will be archived to allow traceability of the development process
and transparency regarding the changes implemented.
The file should provide a compilation of all the necessary documentation for
successful technology transfer and initial commercial scale manufacture. This
documentation must contain the science and knowledge as well as risk manage-
ment to enable the repeated and reliable manufacture of batches while controlling
(C)PPs in order to ensure that each of the (C)QAs is achieved. A vital part of
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