Member Services
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.
ISPE Good Manufacturing Practice Posters
Display ISPE GMP Posters in common areas to remind employees on the importance of maintaining a GMP lifestyle for product quality assurance and good business practice. Titles include: Performance and Compliance, Ten Principles, Troubleshooter, Putting the Good, State of Control, and many others.
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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 (DVD)
This DVD is intended for operations and line employees and provides a basic introduction to GMP for the pharmaceutical industry. 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 DVD is a brief guide with discussion questions and an employee quiz.
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They Trust Us - Medical Device Industry (DVD)
This DVD program 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 DVD is a brief guide that includes discussion questions. In addition, a set of questions/answers has been included as a “quiz” for employees who have viewed the DVD.
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GMP: Why Do We Need It? (DVD)
This DVD 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.
21 CFR Part 11: Electronic Signatures
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The 21 CFR Part 11 mini-handbook is used in association with ISPE training course Basic Concepts of Validation. Attendees of the training course receive a complimentary copy of this publication.
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21 CFR Part 820: Medical Devices
The Medical Devices mini-handbook is used in association with several ISPE training courses: |
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Attendees of the training course receive a complimentary copy of this publication. |
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21 CFR Part 608 (Blood)
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The Blood mini-handbook is used in association with ISPE training course GMP Fundamentals for the Biotechnology Industry. Attendees of the training course receive a complimentary copy of this publication
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21 CFR Part 210 & 211: Pharmaceutical
The Pharmaceutical mini-handbook is used in association with several ISPE training courses: |
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Attendees of the training course receive a complimentary copy of this publication. |
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ICH Q7A
The ICH Q7A mini-handbook is used in association with several ISPE training courses:
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Attendees of the training course receive a complimentary copy of this publication. |
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