8 Qualification of CE instrumentation

Separation Science and Technology

Volumn 9, Issue , 2008, Pages 171-183

  Puttock, Barrie ^a  

^a Renwood Validation Services Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 47849131181     PISSN: 01496395     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0149-6395(07)00008-6     Document Type: Review

References (6)

1. Analytical Method Validation and Instrument Performance Verification (Chung Chow Chan, Herman Lam, Y. C. Lee, Xue-Ming Zhang, Eds.), ISBN 0-471-25953-5, John Wiley & Sons Inc, Hoboken, New Jersey, USA.
2. Guidance for Industry Q9 Quality Risk Management, United States Food and Drug Administration, June 2006.
3. Harmonised Tripartite Guideline Quality Risk Management Q9 (step 5). In The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 2005.
4. Analysis Techniques for System Reliability - Procedure for Failure Mode and Effect Analysis, IEC 60812, 2nd Edition, International Electrotechnical Commission, Geneva, Switzerland.
5. <1058> Analytical Instrument Qualification, Pharmacopeial Forum\(6), November 2006.
6. Code of Federal Regulations, 21CFR Part 11.