Implementing New Technology in a Regulated Environment - Analytical Validation - page 182

One final recommendation: when implementing a change, equivalency studies
with the old method should always be undertaken to identify potential bias. Method
equivalency is particularly important if the method is changed in between points in
a long-term stability study. The applicant should provide information to explain why
the new method is preferred to the original, including supporting data.
9.7 conclusIon
While it is certainly easier to adopt new technology with new methods rather than
to revalidate current standard methods, implementing new technology can have
a significant return on investment that can make a method modification a very
worthwhile pursuit. By consulting the guidelines and adhering to a few basic prin-
ciples, change can be implemented in a painless exercise that can result in faster,
more sensitive, and more robust information that may even reveal a wealth of new
useful information.
reFerences
1. Swartz, M. E. and Krull, I. S., LCGC 23(10), 1100-1109, October 2005.
2. In-process revision, Pharm. Forum , 31(2), 555, Mar.-Apr. 2005.
3. FDA ORA Laboratory Procedure, #ORA-LAB.5.4.5, Revised 09/09/2005. See also
http://www.fda.gov/ora/science_ref/lm/vol2/section/5_04_05.pdf.
4. Guidance for Industry, Changes to an Approved NDA or ANDA, FDA Center for Drug
Evaluation and Research, Rockville MD, April 2004. See also http://www.fda.gov/cder/
guidance/index.htm.
5. Guidance for Industry, Comparability Protocols-Chemistry, Manufacturing, and
Controls Information, FDA Center for Drug Evaluation and Research, Rockville MD,
February 2003. See also http://www.fda.gov/cder/guidance/index.htm.
6. Furman, W. B., Dorsey, J. G., and Snyder, L. R., Pharm. Technol . 22(6), 58-64, 1998.
7. Pharm. Forum , 31(3), 825, May-June 2005.
8. Pharm. Forum, 31(6), 1681, Nov.-Dec. 2005.
9. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeia Convention, Inc., Rockville, MD, 2011, Chapter <1226>.
10. ISO 9000:2000 clause 3.8.5.
11. ISO 9000:2000 clause 3.8.4.
12. Swartz, M. E., Krull, I. S., and McCabe, J., LCGC , 22(9), 906, 2004.
13. Current Good Manufacturing Practice for the Manufacture, Processing, Packing, or
Holding of a Drug Product, 21 Code of Federal Register (CFR) Part 211; Subpart A:
General Provisions 211.1-Scope.
14. Current Good Manufacturing Practice for the Manufacture, Processing, Packing, or
Holding of a drug Product, 21 Code of Federal Register (CFR) Part 211; Subpart B:
Organization and Personnel 211.25-Personnel Qualifications.
15. Neue, N. D., McCabe, D., Ramesh, V, Pappa, H., and DeMuth, J., Pharm. Forum , in
press, April 2010.
16. Swartz, M. E. and Krull, I. S., LCGC , 23(6), 26, June 2004.
17. Guidance for Industry, Investigating Out of Specification (OOS) Test Results for
Pharmaceutical Production. U.S. Food and Drug Administration, Department of Health
and Human Services, Rockville, MD, September 1998.