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McArdle & Associates Jim McArdle President Tel: (760) 652-5216 Email: Jim McArdle Strategy Regulatory Development Documentation Manufacturing Chemistry Control

Further Information           CMC development strategy     Jim served as deputy topic leader representing PhRMA in creation of the ICH guideline “Pharmaceutical Development” (Q8). Here is a link to that document: http://www.ich.org/LOB/media/MEDIA4986.pdf     cGMP and 21st Century Quality Systems     GMP for active pharmaceutical ingredients is discussed in the ICH guideline “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” Q7. Here is a link to that document: http://www.ich.org/LOB/media/MEDIA433.pdf     GMP for drug product is governed in the United States by laws defined in the Code of Federal Regulations. This this link to 21 CFR 210, 211 at the CDER site is recommended because of its excellent built-in search capability: http://www.fda.gov/cder/dmpq/cgmpregs.htm     This link will take you to the ICH guidance on risk management (Q9). http://www.ich.org/fileadmin/Public Web Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf     Here is a link to an informative report from the FDA on progress in implementing the new system. http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm     Analytical development     Here is a link to ICH guideline Q2, “Validation of Analytical Procedures,” which discusses the methodology behind appropriately validated methods. http://www.ich.org/LOB/media/MEDIA417.pdf     Stability study design and data interpretation     Here are the links to the ICH stability guidelines:     Q1A, “Stability Testing of New Drug Substances and Products” http://www.ich.org/LOB/media/MEDIA419.pdf     Q1B, “Photostability Testing of New Drug Substances and Products” http://www.ich.org/LOB/media/MEDIA412.pdf     Q1C, “Stability Testing for New Dosage Forms” http://www.ich.org/LOB/media/MEDIA413.pdf     Q1D, “Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products” http://www.ich.org/LOB/media/MEDIA414.pdf     Q1E, “Evaluation of Stability Data” http://www.ich.org/LOB/media/MEDIA415.pdf     Preparation of applications for clinical trial or marketing authorization     Here is a link to guideline for the Quality section of the Common Technical Document (CTD-Q). http://www.ich.org/lob/media/media556.pdf     Out-of-specification investigations     Here is a link to a paper that Jim co-authored on OOS results, which you might find helpful. "Investigation of Out- of-Specifications Results."

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