Chemistry Reference
In-Depth Information
are used to assess a product's quality and availability for shipment. The training
required for different laboratory functions and levels as well as each individual's
training record should be documented and reviewed regularly, and available to audit
upon request.
Finally, it is interesting to note that in today's environment, there is pressure to
use competency-based testing and training to prove understanding or certification,
as opposed to having a record of attendance alone accepted as training. Though this
is a step in the right direction, its implications should be considered from the stand-
point of cost in both money and time. It should be considered in light of the goals
that are to be attained. It also should be understood from the standpoint of any given
company and its philosophies that competency-based training should be required at
all points in the training process.
1.8 conclusIon
In today's global market, the development of a new drug is a long and costly process,
involving regulatory, governmental, and sanctioning bodies from around the world.
A well-defined and documented validation process is what provides regulatory agen-
cies with evidence that the system (instrument, software, method, and controls) is
suitable for its intended use.
reFerences
1. http://www.fda.gov/cder/handbook/develop.htm.
2. FDA Guidance for Industry, IND's for Phase 2 and 3 Studies of Drugs, Chemistry,
Manufacturing and Controls, Content and Format, Draft Guidance, CBER and CDER,
February 1999. See http://www.fda.gov/cder/guidance/guidance.htm.
3. Boudreau, S. P., McElvain, J. S., Martin, L. D., Dowling, T., and Fields, S. M., Method
validation by phase of development, an acceptable analytical practice
, Pharm. Technol.
,
p. 54, November 2004.
4. DiMasi, J. A., Hansen, R. W., and Grabowski, H. G., The price of innovation: New esti-
mates of drug development costs,
J. Health Economics
, 22, 151, 2003.
5. Tufts Center for the Study of Drug Development, Press release Nov. 9, 2006, and May
13, 2009. See http://csdd.tufts.edu.
6. http://www.fda.gov/opacom/morechoices/mission.html.
7. ICH Q2A: Text on validation of analytical procedures,
International Conference on
Harmonization of Technical Requirements for the Registration of Drugs for Human Use,
Geneva,
Switzerland, March 1995,
Fed. Reg.
, Vol. 60, March 1, 1995, p. 11260. See also
www.ich.org.
8. ICH Q2B: Validation of analytical procedures: Methodology,
International Conference
on Harmonization of Technical Requirements for the Registration of Drugs for Human
Use,
Geneva,
Switzerland, May 1997,
Fed. Reg.
, Vol. 62, No. 96, May 19, 1997,
pp. 27463-27467.
See also www.ich.org.
9. ICH Q2 (R1): Validation of analytical procedures: Text and methodology,
International
Conference on Harmonization of Technical Requirements for the Registration of Drugs
for Human Use,
Geneva, Switzerland, November 2005. See also www.ich.org.
10. United States Food and Drug Administration, Guideline for submitting samples and
analytical data for methods validation, February 1987. US Government Printing Office:
1990-281-794:20818, or at www.fda.gov/cder/analyticalmeth.htm.
