GMP Products and Publications

The GMP Institute (GMPI), founded in 1977 to help companies comply with FDA's GMP regulations, was acquired by ISPE in 2000. The philosophy of the GMPI is simple - GMP makes good business sense because it helps a company to implement practices assuring the quality of their products. The products listed in this section are original to the GMP Institute.

Medical Device Quality Systems Manual

Published:December 1996 Pages: 300+ This manual is FDA’s interpretive guide to the new Quality System Regulation. It covers aspects of manufacturing including the new design control requirements and it contains model procedures and sample forms. This is a must-have for every medical device manufacturing plant!

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10 Principles of GMP (DVD)

This DVD introduces employees to 10 critical behaviors established by the FDA and industry leaders to maintain Good Manufacturing Practices (GMPs) in a plant. Use the 10 Principles of GMP to build a foundation for consistent and compliant performance. This DVD is a must see for all new personnel. You will see how quickly and easily you can draw from any of the principles to reinforce correct behavior for all employees.

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Doing Our Best - Pharmaceutical Industry (Video)

This two-volume videotape series is intended for operations and line employees and provides a basic introduction to GMP for pharmaceutical and medical device industries. It presents a practical approach and builds a common language of GMP among your employees as well as stressing the importance of GMP compliance for everyone within your organization. Included with the videotape is a brief guide with discussion questions and an employee quiz.

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They Trust Us - Medical Device Industry (Video)

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GMP: Why Do We Need It? (Video)

This videotape takes a retrospective look at the food and drug adulterations that led to the formation of the FDA and the evolution of its regulations. It summarizes the various historical events and impact of the media that led to the development of the laws and quality measures that currently exist. It also examines how the FDA has strengthened control with regulations and Good Manufacturing Practice (GMP).

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Mini Regulation Handbooks

These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines. They are an exact copy of the FDA documents.