Analytical Method Validation for Biopharmaceuticals: A Practical Guide - - BioPharm International

ADVERTISEMENT

Analytical Method Validation for Biopharmaceuticals: A Practical Guide


BioPharm International


References 1. FDA. 21 CFR 211, Sections 165(e) and 194(a)(2). Available at: http://www.fda.gov/.

2. PDA. Evaluation, validation and implementation of new microbiological testing methods: PDA Technical Report No. 33. PDA Journal of Pharmaceutical Science and Technology 2000; 54(Suppl. TR33).

3. ICH. Validation of Analytical Procedures. Q2A. Federal Register 1995; 60.

4. ICH. Validation of Analytical Procedures: methodology. Q2B. Federal Register 1996; 62.

5. United States Pharmacopoeia. USP 28 <1225>. Validation of Compendial Methods.

6. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part I: development and optimization. BioPharm International 2004; 17(10):52-61.

7. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part II: formal validation. BioPharm International 2004; 17(11):46-52.

8. CDER. Guidance for Industry. Bioanalytical Method Validation. Bethesda MD: FDA; 2001.

9. CBER. Draft Guidance for Industry. Analytical Procedures and Methods Validation. Bethesda MD: FDA; 2000.

10. Ritter N., et al. What is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess International 2004; 2(8):32-47.

11. Krause SO. Good analytical method validation practice, part I: setting-up for compliance and efficiency. Journal of Validation Technology 2002; (9):23-32.

12. Krause SO. Good analytical method validation practice, part II: deriving acceptance criteria for the AMV protocol. Journal of Validation Technology 2003; (9):162-78.

13. Krause SO. Good analytical method validation practice, part III: data analysis and the AMV report. Journal of Validation Technology 2003; (10):21-36.

14. Krause SO. Analytical method validation. Presented at IVT's 10th Annual Meeting; 2004 Feb 25-28; Philadelphia, PA.

Stephan O. Krause, Ph.D., validation manager of QC assay support, Bayer HealthCare LLC, 800 Dwight Way, Berkeley, CA, 94701-1986, 510.705.4191,


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Yale and Gilead Extend Sequencing Initiative
October 28, 2014
Contract Research and Manufacturing Organization Paragon Bioservices Raises $13 Million
October 28, 2014
Novartis Sells Influenza Vaccine Business to CSL for $275 Million
October 27, 2014
Author Guidelines
Source: BioPharm International,
Click here