Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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28 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Likewise, drug product or drug substance com- positions or processes may lead to valuable intel- lectual property, be it patents or know how. Thus, legal and CMC representatives need to coordinate their activities. In conclusion, CMC-related activities should be considered a crucial part of any due diligence exercise. The CMC area includes a number of dis- tinct disciplines and thus, needs to be addressed by individuals with appropriate experience. It is hoped that this article provides a sound foundation for carrying out an effective due diligence exercise. References 1. A. Shanley, Pharm. Tech., 42(11) 20–56 (2018). 2. T.J. DiFeo, Drug Devel. Indust. Pharm. 29(9) 939–958 (2003). 3. T.J. DiFeo, Pharm. Eng., 24(2) 8–18 (2004). 4. T.J. DiFeo, Pharm. Eng., 25(2) 66–100 (2005). 5. FDA, Inspection Classification Database, www.accessdata.fda. gov, accessed May 20, 2020. 6. FDA, Warning Letters, www.fda.gov, accessed May 22, 2020. PT Process Development Table II. Regulatory agency guidelines for chemistry, manufacturing, and controls for different stages of drug development. Agency Document (click title to download PDF) Date FDA FDA Guidance for Industry, CGMP for Phase 1 Investigational Drugs July 2008 FDA Guidance for Industry, INDs for Phase 2 and Phase 3 Studies, Chemistry, Manufacturing, and Controls Information May 2003 FDA Guidance for Industry, Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products November 1995 European Medicines Agency Guideline on the Requirements for the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials September 2017 European Medicines Agency Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials September 2018 Intellectual property, costs, and timelines Formulation Regulatory filings and communications API Analytical Manufacture Packaging and devices Figure 1. Major CMC areas to consider. FIGURE COURTESY OF THE AUTHOR.

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