Full Description

Issue 27: includes revisions to Section 8 (173i27). Section 8 contains requirements for Good Manufacturing Practices (GMPs), which prior to this revision was based on the GMPs submitted by industry to the U.S. Food and Drug Administration (USFDA) in November 1995.Issues 14 and 21 are superseded by this issue.

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Published: 04/21/2008 ANSI: ANSI Approved Number of Pages: 36