Articles by Paula J. Shadle, PhD - BioPharm International

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Articles by Paula J. Shadle, PhD

Managing the Global Supply Chain

Recent events have highlighted the need for action with regards to how we handle materials from abroad.
May 1, 2008

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

Writing Effective Development Reports

How to Document a Scientific Process
Sep 2, 2006

Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.

Overview of GMPs

Nov 15, 2004

What are current good manufacturing practices (cGMPs)? Where did they come from? What are the actual "practices" described in the Code of Federal Regulations, 21 CFR. If you are new to the pharmaceutical or biotechnology industries, you may enter your first "GMP Training" session without much context or perspective. A set of arcane rules is presented; you were never taught these in science classes.

BSE Offers Lessons in Risk Assessment

The key to managing the risks of food-borne diseases, including bovine spongiform encephalopathy, lies in assessing relative risk and appropriately allocating limited resources.
Jul 1, 2004

The approaches taken to containing the risk of BSE reveal patterns in the difficulties of performing and reacting appropriately to risk analysis.

Qualification of Raw Materials for Biopharmaceutical Use

Setting up a proactive system for raw materials qualification ensures a constant supply of materials of appropriate quality and enhances the safety and consistency of a pharmaceutical product.
Feb 1, 2004

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

GMP Issues: Moving QA onto the Manufacturing Floor

Aug 1, 2003

Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?

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