A Guide for Testing Biopharmaceuticals Part 1: General Strategies for Validation Extensions - - BioPharm International


A Guide for Testing Biopharmaceuticals Part 1: General Strategies for Validation Extensions

BioPharm International
Volume 19, Issue 9

No matter which comparability category we may use for a statistical comparison (with ρ = 0.05), a protocol should provide the design of experiments to be done and the pre-specified value for the allowable difference in results. The prespecified maximum allowable difference is illustrated in CPMP's Points to Consider On The Choice Of Non-Inferiority Margin.19 The allowable difference should be set similar to AMV or AMT. The difference should be set and justified by relating specifications to SPC data and considering the likelihood of observing any of the four cases (1A, 1B, 2A, and 2B).13

Stephan O. Krause, PhD, is the manager of QC Technical Services and Compendial Liaison at Bayer HealthCare , LLC, Berkeley, CA 94701, tel. 510.705.4191,


1. Guideline for Industry Text on Validation of Analytical Procedures, ICH Q2A, 60, 1995. http://www.fda.gov/cder/guidance/ichq2a.pdf

2. Guidance for Industry Q2B Validation of Analytical Procedures: Methodology, ICH Q2B, 62, 1996. http://www.fda.gov/cder/guidance/1320fnl.pdf

3. The Fitness for Purpose of Analytical Method, Eurachem, Teddington, UK (1998). http://www.eurachem.ul.pt/guides/valid.pdf

4. Traceability in Chemical Measurement, Eurachem/CITAC, Teddington, UK (2003). http://www.eurachem.ul.pt/guides/EC_Trace_2003.pdf

5. Guidance for Industry, Bioanalytical Method Validation (2001). http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm

6. Draft Guidance for Industry, Analytical Procedures and Methods Validation (2000). http://www.fda.gov/cder/guidance/2396dft.htm

7. Technical Report 33, Evaluation, Validation and Implementation of New Microbiological Testing Methods (PDA, Bethesda, MD, USA).

8. Alternative Methods For Control of Microbiological Quality, EP. Supplement 5.5 [07/2006:50106] (December 2005). http://www.pheur.org/

9. S.O. Krause, BioPharm Int. 17(3), 28–36 (2004).

10. S.O. Krause, BioPharm Int. 17(10), 52–61 (2004).

11. S.O. Krause, BioPharm Int. 17(11), 46–52 (2004).

12. S.O. Krause, BioPharm International Validation Guide, a supplement to BioPharm Int. 18(3) (2005).

13. S.O. Krause, BioPharm International Guide to Bioanalytical Advances, a supplement to BioPharm Int. 18(9) (2005).

14. S.O. Krause, BioPharm Int. 18(10), 52–59 (2005).

15. Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004). http://www.fda.gov/cder/guidance/6419fnl.pdf

16. ISPE Good Practice Guide: Technology Transfer (International Society for Pharmaceutical Engineering, Tampa, FL, 2003).

17. Statistical Principles for Clinical Trials, ICH E9 (1998). http://www.emea.eu.int/pdfs/human/ich/036396en.pdf

18. Points to Consider on Switching Between Superiority and Non-Inferiority, CPMP (2000). http://www.emea.eu.int/pdfs/human/ewp/048299en.pdf

19. Points to Consider On The Choice Of Non-Inferiority Margin, CPMP (2004). home.att.ne.jp/red/akihiro/emea/215899en_ptc.pdf

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