BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 1

BACKGROUND AND INTRODUCTION

HAROLD S. BASEMAN AND A. HAMID MOLLAH

Companies wishing to manufacture and distribute regulated health care products
to the population of the United States must comply with the U.S. Food and Drug
Administration (FDA) regulations, better known as Current Good Manufacturing
Practices (CGMPs). 21 CFR 211.100 of U.S. CGMPs states “There shall be
written procedures for product and process control designed to assure that drug
products have identity, strength, quality, and purity they purport or are represented
to possess ... ”[1]. Regulations are a legal requirement and this CFR, among
others, mandates that companies must take active steps to assure product quality.
Companies and individuals working for health care industries have an obliga-
tion to provide products that are safe and effective to their customers, users, and
patients. The regulations codify this obligation, thus making it a legal require-
ment; but the obligation to provide safe and effective products is also a moral
and ethical obligation that goes beyond the legal regulatory requirements. People
working for pharmaceutical companies also have a duty of loyalty to operate for
the welfare of the company. In other words, they have an additional obligation
to operate efficiently and earn optimal profits within the framework of regulatory
requirements and ethics. Companies and individuals must be able to align these
legal requirements and business obligations.
The failure to provide safe and effective products will likely result in loss of
business as well as other legal consequences. However, in recent years, it seems
that the industry has faced pressure and challenges to balance these requirements
and obligations. It has become more difficult to remain in compliance, serve