Madhu,
If you are conducting pivotal toxicology studies (IND enabling?), you should be following GLP requirements which include full characterization of the test article (whether GMP or not), validated methods or appropriately qualified (SLAP), perform impurity identification depending on level of the impurity (this is the purpose of the GLP pivotal study to qualify the impurities and establish safety margins for the clinical trial); and place the test article on stability (stability indicating methods for impurities). If IND enabling, follow the guidance on tox requirement for Phase 1 studies. The formulated product from the test article should also be placed on stability and any degradation products identified for qualification during the GLP study. Don't only focus on DS as you are evaluating the formulated product (test article) that will be used to support the clinical trial, correct?
Hope this helps,
Dar
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Darlene Rosario, BS, RAC, MBA
Oxnard CA
United States
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Original Message:
Sent: 06-26-2012 14:37
From: Madhu Singh
Subject: Analytical method qualification for nonGMP DS
This message has been cross posted to the following Discussions: Canadian Regulatory Open Forum and Regulatory Open Forum .
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Hello All,
To what extent should the analytical method be validated/qualified for release of nonGMP DS (to be used for GLP tox studies)? To what extent ICH Q2 should be followed at this stage? API is a small molecule.
In addition, should one be performing impurity characterization and have stability indicating methods at the GLP tox stage?
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Madhu
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