Volume 21, Number 3

Table of Contents

Articles

Reasons

by Brian W. Saxton
This article discusses what are the elemental requirements of a Validation Master Plan, what it should look like, what the FDA expects, and what level of detail should be included.

Product Protection in the Pharmaceutical Industry – Meeting the Challenge

by Hitesh Patel
This article examines developments in metal detection in the pharmaceutical industry and highlights some of the contamination issues producers should be aware of.

Increasing Value Through the Measurement of the Cost of Quality (COQ) – A Practical Approach

by Guy Malchi, Helen McGurk
The concept of the cost of quality is a powerful idea and as profits and quality are integrally linked, it is imperative that the cost of quality is tracked, giving managers the ability to control these costs and providing a focus for improved quality at reduced cost

FDA Regulations of Computer Systems in Drug Manufacturing – 13 Years Later

by Orlando Lopez
The objective of this article is to go through regulatory requirements applicable to complex systems in the manufacturing environment.

Automation of the Documentation Preparation Process in an Automated

by Rodger Edwards, John McNulty
This article provides an overview of an IT tool that addresses the process documentation and recipe preparation and approval process in a multi-product, multi-purpose, bulk pharmaceutical manufacturing facility.

Automated Material Handling for Pharmaceutical Applications

by Patrick J. Conway
Automated material handling within the pharmaceutical industry increases safety, reduces manpower and product damage, and provides automatic load tracking to facilitate regulation compliance.

Flexible Batch Automation and Reporting Software Designs for Active Pharmaceutical Ingredients (APIs)

by Bob Carrier
This article describes a cost effective approach to flexible batch process computerized control and data reporting appropriate for implementation in a GMP compliant mult-process, multi-product, API manufacturing facility.

Biowaste Systems

by Carl J. Carlson
This article discusses key design considerations for pharmaceutical production plant Liquid Waste Decontamination System (LWDS) design and validation.

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