 |
|
 |
|||||||||
|
Pharmaceutical Engineering Archives |
|||||||||
Volume 14, Number 3 |
|||||||||
| An FDA Perspective on Bulk Pharmaceutical Chemical GMPs, Control and Validation by Edwin Rivera Martinez Discusses FDA’s approach to the regulation of BPC’s, agency guidance documents and FDA’s expectations regarding the manufacturing, control and validation of BPC processes.  Download Article... |
Mobile Manufacturing Systems, Pharmaceutical Engineering Response to the New Health Care Industry by Henry D. Rahe & Ann L. Szatmary This article describes a concept to design and construct cost effective, flexible facilities through the use of barrier/isolation technology. Download Article... |
A Quality Assurance Design Inspection Program for Process Validation Including a Case Study for a Bulk Pharmaceutical Chemical Plant by Joseph G. O'Hara & Alfred G. Thompson Quality Assurance Design Inspection Program is a method for examining and identifying GMP problems in facility design. Download Article... |
ISO 9000 and the Pharmaceutical Industry: An Overview by Carol Landsman, Paul J. Moran & Salvatore J. Romano, PhD The impact of ISO 9000 on the pharmaceutical industry is reviewed. Download Article... |
Pharmaceutical Engineering's Interview with Richard R. Klug by Richard R. Klug An interview with the Director of the International and Technical Operations Branch (ITOB) of the FDA. Download Article... |
European Medicines Agency: A Help or Hindrance? by Pamela A. Jones An explanation of the role of the European Medicines Agency. Download Article... |
GATT and NAFTA: The Technical Barriers to Trade Agreements and Pharmaceutical Harmonization by Linda R. Horton Technical barriers to trade agreements relative to international harmonization of pharmaceutical regulation. Download Article... |
An Integrated Approach to Process Validation by Ganesan Bala A systematic approach to process validation using project management and design of experiments techniques. Download Article... |
|
|
|
 |
|
