Global Sterile Manufacturing Regulatory Guidance Comparison (single user digital version)

Feb 2016
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PDF Single user
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The publication Global Sterile Manufacturing Regulatory Guidance Comparison: With link to Comparison Spreadsheet compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization.

Within the document, you will find analysis and comparison tables that are easy-to-use references for companies that need to adhere to the four regulatory documents; the spreadsheet allows companies to do their own assessment of their status for each element.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 1.95 MB)

Click here to order paper ship version (Item no. 03006).

Table of Contents

Table of Contents:

  1. Introduction
  2. Analysis
  3. Comparison Table