Good Laboratory Practice
Therefore, exploratory material and chemical characterization studies do not need
to be conducted GLP. However, chemical characterization studies designed to gather
data for a toxicological risk assessment as part of an overall biocompatibility program
(for example, studies described in ISO 10993-18, Chemical Characterization of Materials) should be treated with more care. They likely do not need to be conducted according to GLP, but since these studies may be used in support of a PMA or 510(k) submission, strong quality systems and procedures, including independent quality control
(QC) review of data, are recommended. Additionally, it is prudent to include test article
characterization data and information, as discussed in the next section, when performing these types of biocompatibility-supporting chemical characterization studies.
Recommendations for GLP/non-GLP Conduct
of Device Regulatory Studies
(both in-vivo and in-vitro)
(sterilization validations, GLP (most likely) not needed
reusable device cleaning validations)
Exploratory Studies GLP not needed (non GLP)
Chemical Characterization Studies
(such as ISO 10993-18 Chemical GLP (most likely) not needed
Routine Lot Testing Conduct according to GMP*
(bioburden, endotoxin, sterility)
*GMP is short for good manufacturing practices.
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To understand how to decide what data is
needed for a medical device, it’s important
to consider the problems the GLPs were
meant to address. A primary consideration
is to ensure that the test article is fully
representative of the final product.