Biomedical Engineering Reference
In-Depth Information
pointing,” and “jumping to conclusions” that bedevil
real-world investigations, see Chris Eckert (2008).
16. See 21 CFR 211.198(b)(3), ∫ 106.100(k)(2), ∫ 820.198(b),
∫ 1271.370(b), etc.
17. See, for instance, 21 CFR 820.100 “Corrective and
preventive action,” also ∫ 806.10 “Reports of
Corrections.”
18. As the ICH (2008) has pointed out, “CAPA methodology
should result in product and process improvements and
enhanced product and process understanding.” This
highlights the role of remediation in continuous
improvement.
19. A regulatory inspection could be conducted by the EPA
(focusing on emissions and waste), the DEA (controlled
substances), etc. Chapter 6 discusses the regulatory
overlap between these various agencies. This present
chapter limits the discussion to the FDA.
20. See the FDA
Investigations Operations Manual
(2008)
Sect. 5.1.2, “Inspectional Approach,” and Sect. 5.51
“Drug Inspections.”
21. See the FDA guidance
Quality Systems Approach to
Pharmaceutical cGMP Regulations
(2006); also Karyn
Campbell (2008).
22. 21 CFR 310.305(b) “Records and Reports.”
23. 21 CFR 310.305(a) “Records and Reports.”
24. See also Robert Nelson,
et al.
(2002). Note that the
reporter could be anyone, including the patient. Most
organizations require that an employee report within
one business day if a person complains about some
physical problem or symptom and mentions they are
taking one of the organization's products.
25. 21 CFR 310.305(c)(1), “Post-marketing 15-day 'Alert
reports'.” Many organizations provide these reports in
seven days. In addition, AEs relating to a regulated
