Analytical Method Validation: Principles and Practices

Pharmaceutical Manufacturing Handbook: Regulations and Quality

Volumn , Issue , 2007, Pages 725-742

  Chan, Chung Chow ^a  

^a Azopharma Contract Pharmaceutical Services   (United States)

Author keywords

Detection limit and quantitation limit; Intermediate precision; Phase appropriate method validation

Indexed keywords

EID: 84889864345     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470259832.ch22     Document Type: Chapter

References (8)

1. International Conference on Harmonization (ICH) (2005, Nov.), Harmonised tripartite guideline Q2(R1), Validation of analytical procedures: Text and methodology.
2. International Conference on Harmonization (ICH) (1999, Oct.), Harmonised tripartite guideline Q6A, Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances.
3. International Conference on Harmonization (ICH) (2000, Nov.), Harmonised tripartite guideline Q7A GMP for active pharmaceutical ingredient.
4. International Conference on Harmonization (ICH) (2006, Sept.), Guidance for industry:Quality systems approach to pharmaceutical cGMP.
5. Code of Federal Regulations (CFR), Part 211, Current good manufacturing practice for finished pharmaceuticals.
6. Chan, C. C., et al., (2004), Analytical Method Validation and Instrument Performance Verification, J Wiley, Hoboken, NJ.
7. U.S. Pharmacopeia (USP), General Chapter < 1225 >, Validation of compendial procedures, USP, Rockville, MD.
8. U.S. Pharmacopeia (USP), General Chapter < 1226 >, Verification of compendial procedures, USP, Rockville, MD.