Validation, qualification, or verification?

LC-GC North America

Volumn 23, Issue 10, 2005, Pages 1100-1109

  Swartz, Michael E ^a   Krull, Ira S ^b  

^a WATERS CORPORATION   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27644454204     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. www.ich.org.
2. M.E. Swartz and I.S. Krull, Analytical Method Development and Validation (Marcel Dekker, New York, 1997).
3. AAPS PharmSciTech 2004, 5(1) Article 22 (http://www.aapspharmscitech.org) .
4. ICH Q3A(R), "Impurities in New Drug Substances," Federal Register 68(68), 6924-6925. See also: www.ich.org.
5. ISO 9000:2000 clause 3.8.5.
6. ISO 9000:2000 clause 3.8.4.
7. Pharmacopeial Forum 31(2), 549 (Mar./Apr. 2005).
8. ICH Q2A, Federal Register 60, p. 11260. See also www.ich.org.
9. Pharmacopeial Forum 31(2), 555 (Mar./Apr. 2005).
10. M.E. Swartz, I.S. Krull, and J. McCabe, LCGC 22(9), 906 (2004).
11. Current Good Manufacturing Practice for the Manufacture, Processing, Packing, or Holding of a Drug Product, 21 Code of Federal Register (CFR) Part 211; Subpart A: General Provisions 211.1-Scope.
12. Current Good Manufacturing Practice for the Manufacture, Processing, Packing, or Holding of a drug Product , 21 Code of Federal Register (CFR) Part 211; Subpart B: Organization and Personnel 211.25-Personnel Qualifications.
13. M.E. Swartz and I.S. Krull, LCGC 23(6), 47 (2005).
14. M.E. Swartz and I.S. Krull, LCGC 16(10), 922 (1998).