Biomedical Engineering Reference
In-Depth Information
product are reviewed every six months for each regulated
product and an updated report is fi led with the FDA.
26. Remediation may involve a “Dear Investigator Letter”
(DIL) if it is observed during a clinical trial. A DIL is
prepared if an AE occurs during a clinical trial and is
confi rmed or reasonably certain to be related to the
regulated product. Incidentally, the term CAPA is rarely
used in clinical studies. If this is a post-marketing trial
or observation, then changes to the labeling may be
considered.
27. 21 CFR 820.3(b), “Defi nitions.”
1.8 References
Barsky, E., Grunbaum, L. (2008) The “business” of
investigations.
J. GXP Comp.
12(5), 90-6.
Bartholomew, D. (2006) CAPA and root cause analysis.
Pharma. Manu.
5(4).
Campbell, K. (2008) FDA Risk-based Inspection Model,
presented at
Validation Week
, Philadelphia, PA, 22
October 2008.
Eckert, C. (2008) Eliminating defects in the vertical supply
chain.
Qual. Dig.
28(12), 24-6.
FDA (2006),
Guidance for Industry: Quality Systems
Approach to Pharmaceutical cGMP Regulations
,
Rockville, MD: CDER/CBER, September 2006.
FDA (2008)
Investigations Operations Manual
, Rockville,
MD: ORA.
Fields, T. (2008) Auditing as a component of a pharmaceutical
quality system.
J. GXP Comp.
12(5), 61-8.
Heuvel, L.V., Robinson, C. (2005) How many causes should
you pursue?
J. Qual. Particip.
28(2), 22-3.
