PDA Technical Report No. 59 (TR 59) Utilization of Statistical Methods for Production Monitoring (single user digital version)

Nov 2012
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The purpose of Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring is to present relevant and easy to use Statistical Process Control Methods that are applicable to our industry.

The Technical Report is the latest produced as part of PDA's Paradigm Change in Manufacturing OperationsSM initiative.

PDA's Latest Technical Report Demystifies Statistical Methods
The pharmaceutical industry has seen increasing recognition in the role of statistical methods. As manufacturers seek to consistently produce products that conform to predetermined quality characteristics, statistical methods have historically shown their value in providing objective evidence in meeting this goal. Statistics are also fundamental for the process understanding that is requisite for process improvement and development.

Industry and regulatory bodies like the International Committee for Harmonization, the International Standards Organization and the European Union have provided guidance on the use of statistical methods.

To help facilitate this process, PDA's Utilization of Statistical Methods for Production and Business Processes Task Force has produced a technical report that provides guidance in identifying and using statistical methods. The primary objective of this task force was to convey the appropriate use of statistical methods at a level most can understand.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Statistical Process Control Tools
  4. Acceptance Sampling
  5. Appendices: Technical Details and Examples
  6. References
  7. Additional Reading
  • Figures and Tables Index