Documentation Basics That Support Good Manufacturing Practices

The documentation system described in this text is designed to support Good Manufacturing Practices (GMP) in a medical manufacturing environment. However, the usefulness of the system can be extended to other areas of a corporation (development, clinicals, marketing, finance, as well as to many other unrelated, nonmedical industries). The principles & the decision making inherent in documentation system design remain the same, no matter what the product or business. The book describes the creation, use & control of the descriptive documents, data collection documents, numbering systems & data files that are appropriate for use in an industry subject to Good Manufacturing Practices. The text was written as a guideline for the individuals who must design the systems & work with them routinely. The descriptive documents presented in this book are designed to serve two purposes: to direction task-specific events & to educate the reader about the event in a manner that supports responsible decision making. It presents the major components of a GMP documentation system, gives examples of design, format & content, & explains how these components interact. $US42.95 plus shipping & tax where applicable. Call or write Advanstar Communications, Marketing Services; 7500 Old Oak Boulevard; Cleveland, OH 44130. 216-826-2839 or 800-598-6008.DeSain, Carol is the author of 'Documentation Basics That Support Good Manufacturing Practices' with ISBN 9780943330303 and ISBN 0943330300.