Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

CHAPTER 1

UNDERSTANDING THE REGULATIONS

INTRODUCTION

Therapeutic products in development or in the marketplace require extensive and complete documentation. The position of the regulators in the United States and abroad is this: “If you didn't write it down, it didn't happen.” What this caveat means is that companies must produce documentation through every phase of product development, manufacture, and distribution. But producing the documents is hardly enough if a company cannot lay its hands on the documents it needs when it needs them. Good documentation thus requires good controls. The way a company determines what controls it must put in place is first by understanding what documents it must have as proof of sound testing and control of its products to demonstrate that they are both safe and effective. Government agencies dictate what companies must do. Companies, in turn, institute good practices that show adherence to the agency requirements. This chapter addresses the regulatory environment and answers the following questions:

1. What agency in the United States oversees therapeutic products, and what authority does it have?
2. What do I need to know about the regulations?
3. How do regulations come to be?
4. What is the history of the regulations for therapeutic products in the United States?
5. Where can I find the actual regulations?
6. What is the purpose of the regulations, and must ...