Dear All,
I think it depends and not "always" to use GLP (non-GMP) materials for a long term tox study is the best practice. For example, if the tox study is planned concurrently with the phase 3 study to support product registration or license application or as a post approval commitment required by the FDA, it is not advisable to use an "old" GLP or non-GMP lot to conduct the chronic long-term tox study because it is not easy to establish CMC analytical comparability (for large molecule) or equivalency (for small molecule) against already established GMP late phase clinical lots. A GMP lot representative to phase 3 and/or commercial batches is highly recommended to avoid risks that analytical comparability cannot be established and the chronic tox study results cannot be utilized to support product registration or satisfy post approval commitment.
I agree that before phase 1 or concurrently with phase 1, a GLP lot is often recommended for tox studies with exception for some ultra long-term tox study (e.g., =/>2 years, rodent or non-rodent).
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Gene Zhu
Independent Consultant
Basking Ridge NJ
USA
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Original Message:
Sent: 23-May-2019 12:28
From: Victor Mencarelli
Subject: Long term preclinical tox studies
In my opinion it is ALWAYS best to use GLP material because as was said in other threads, the level of development dictates the level of requirements for FDA to accept. Thinking about this logically, you "GLP" material is managed under a defined system of how to make it, what to do with it once it is made, how to store it, how to test and what to test for, etc. So you are covered with your process. Since these are preclinical in my mind this is sufficient.
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Victor Mencarelli
Director Regulatory Affairs
United States
Original Message:
Sent: 23-May-2019 08:49
From: Vincent Benn
Subject: Long term preclinical tox studies
Can non-GMP material be used in these studies? We have "GLP" grade material prepared but want to make sure FDA will accept it before we submit the protocols for FDA comment.
Vincent J. Benn, Ph.D., MBA