PDA Survey: Business Case for Pharmaceutical Quality (single user digital version)

Dec 2012
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PDF Single user
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This 2011 PDA benchmarking survey explores the business case for pharmaceutical quality by examining the cost of poor quality and the essential role of good quality systems in the pharmaceutical industry. The survey was open to the membership of PDA, ISPE and several other industry associations.

Included in this 56-page book are the answers to 95 questions that paint a picture of how quality is supported throughout the company. The questions are broken into seven general categories: General Company Information, General Facility, Quality Organization, Quality Tools, Quality Metrics, Quality System and Quality Regulation. Over 60 respondents participated in the survey representing companies of all sizes and manufacturers of various product types.

The book includes a three-page introduction, which includes an extensive list of conclusions and opportunities derived from the survey results. The PDA Task Force that developed the questions and analyzed the results includes officials from the U.S. FDA, large bio/pharmaceutical companies, and well-respected consulting firms.

Available to download
Format: PDF (1 file 4.49 MB)

Click here to view the digital downloading instruction and Terms of Usage

Table of Contents

Table of Contents:

  • Introduction
  • General Company Information (Questions 1-8)
  • General Facility (Questions 9-25)
  • Quality Organization (Questions 26-39)
  • Quality Tools (Questions 40-57)
  • Quality Metrics (Questions 58-89)
  • Quality System (Questions 90-94)
  • Quality Regulation (Question 95)