A Literature Review of Pharmaceutical Process Validation

Helle, Marjo-Riita; Yliruusi, Jouko; Mannermaa, Jukka-Pekka
March 2003
Pharmaceutical Technology Europe;Mar2003, Vol. 15 Issue 3, p52
Trade Publication
Presents a literature review of pharmaceutical process validation. Definitions of pharmaceutical process validation; Confusion on what constitutes process validation; Historical background on process validation; U.S. Food and Drug Administration's interpretations of process validation. INSET: Current definition of pharmaceutical proces validation.


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