44 BioPharm International eBook October 2020 www.biopharminternational.com
together. Likewise, drug product
or drug substance compositions
or processes may lead to va lu-
able intellectual propert y, be it
patents or know how. Thus, legal
and CMC representatives need to
coordinate their activities.
I n c onc lu sion, C MC - r e l ate d
activities should be considered a
crucial part of any due diligence
exercise. The CMC area includes
a number of distinct disciplines
and thus, needs to be addressed
by individuals with appropriate
experience. It is hoped that this
article provides a sound founda-
tion 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.
BP
Regulatory Sourcebook Process Development
Figure 1. Major chemistry, manufacturing, and controls areas to consider.
Intellectual property,
costs, and timelines
Formulation
Regulatory
filings and
communications
API
Analytical
Manufacture
Packaging
and devices
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
Table II. Regulatory agency guidelines for chemistry, manufacturing, and controls for different stages of drug development.
Figure
courtesy
of
the
author.
