PDA Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (single user digital version)

Published
Nov 2013
ISBN
9780939459629
Pages
53
PDA Item Number
43511

Premium Members: to claim your annual free technical document download, email membership@pda.org and indicate the document you wish to claim.

Format
PDF Single user
Member Price
$180.00
Nonmember Price
$325.00
Government Price
$180.00

Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to illustrate the adaptability of quality risk management tools to help solve various problems, implement corrective actions, and keep processes in a state of control.

Available to download
Format: PDF (1 file 1.37 MB)

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

*To purchase licensing, please contact PDA at info@pda.org.

Click here to order paper ship version (Item no. 01054.3).

Table of Contents

Table of Contents:

Click here to download >>> Detailed Table of Contents
  1. Introduction
  2. Glossary of Terms
  3. Case Study 1: Control of Visible Particulates
  4. Case Study 2: Combination Pharmaceutical/Device Product (Viral Clearance)
  5. Case Study 3: Lyophilization Technical Transfer/Scale-up Risk Analysis
  6. Case Study 4: Melamine Contamination (Supply Chain)
  7. Conclusion
  8. References
  9. Additional Reading

Figures and Tables Index

About the Authors

 

Bookstore Help

Shipping and return policy

Order Inquiries

Booksellers and distributors

Digital download instructions