Perspectives on method validation: Importance of adequate method validation

Quality Assurance Journal

Volumn 13, Issue 3-4, 2010, Pages 72-77

  Bridwell, Heather ^a   Dhingra, Vikas ^a   Peckman, Daniel ^a   Roark, Jennifer ^a   Lehman, Thomas ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; DRUG IMPURITY; DRUG MANUFACTURE; DRUG QUALITY; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; METHOD VALIDATION; PRIORITY JOURNAL; PROCESS CONTROL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; VALIDATION PROCESS;

EID: 80053518665     PISSN: 10878378     EISSN: 10991786     Source Type: Journal    
DOI: 10.1002/qaj.473     Document Type: Review

References (6)

1. U.S. Food and Drug Administration. Title 21 Code of Federal Regulations (21 CFR Part 211.194(a)(2)). Laboratory Records. Available at:. Accessed December 11, 2009.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Guideline Q2(R1): Validation of analytical procedures: text and methodology. Geneva, Switzerland; 1994. Available at: MEDIA417.pdf. Accessed December 11, 2009.
3. United States Pharmacopeial Convention. General chapter <1225>. Validation of compendial procedures. Rockville, Md.: United States Pharmacopeial Convention; 2009.
4. Ritter NM, Advant SJ, Hennessey J, et al. What is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess Int. 2004; 2 (8): 32-46.
5. Kanarek AD,. Method validation guidelines. BioPharm Int Web site. September 15, 2005. Available at: biopharm/article/articleDetail.jsp? id=185606&pageID=4. Accessed December 13, 2009.
6. Boudreau SP, McElvain JS, Martin LD, et al. Method validation by phase of development: an acceptable analytical practice. Pharmaceutical Technology 2004; 28: 54-66. (Pubitemid 39577963)