A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance - - BioPharm International

ADVERTISEMENT

A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance


BioPharm International
Volume 19, Issue 10

REFERENCES

1. S.O. Krause, Pharm. Technol. Eur. 18(5) 2006.

2. S.O. Krause, BioPharm International. 8(10):52–59 (2005).

3. Guidance for Industry (CDER/CVM/ORA, US FDA). PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004.

4. ICH. Pharmaceutical Development, Q8, November 2005.

5. ICH. Quality Risk Management, Q9, November 2005.

6. ICH. Quality Systems. Q10. In draft.

7. S.O. Krause, Analytical Method Validation for Biopharmaceuticals, General Session Presentation, IBC International Conference: Quality Systems and Regulatory Compliance (Reston, VA, April 05, 2005).

8. F. Brown and A. Mire-Sluis (eds): The Design and Analysis of Potency Assays for Biotechnology Products. Dev Biol, Karger, 107(1), 117–127 (2002).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
Author Guidelines
Source: BioPharm International,
Click here