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.