PDA Published Books/Booklets

Global Sterile Manufacturing Regulatory Guidance Comparison (paper ship version)

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.

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Click here to order digital version (Item no. 48000).

Table of Contents:

  1. Introduction
  2. Analysis
  3. Comparison Table

Date of Publication: February 2016
ISBN Number: 9780939459834
Number of Pages: 99
Binding: paper