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Good Manufacturing Practice (GMP) Resources
Good Manufacturing Practice (GMP)
A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Read more of this definition in the ISPE Glossary of Pharmaceutical Technology.
GMP Resources
Online GMP Training: US FDA’s Systems-based GMP Inspection Approach
GMP compliance is widely-accepted as the best way to conduct business, putting product quality first. Representing the “original” GMP Institute, ISPE’s GMP courses combine a convenient format with an effective, interactive learning experience. To maximize and customize your professional development, we have two options available:
Option 1: Complete each of the individual US FDA's GMP Inspection Approach online courses for an overview of all the Systems.
- Quality Systems
- Facilities and Equipment Systems
- Materials Systems
- Production Systems
- Packaging and Labeling Systems
- Laboratory Control Systems
Option 2: Select a Track and complete the pre-requisites, the US FDA GMP Inspection Approach online course, and the electives. We recommend individuals complete the pre-requisite courses before proceeding to the US FDA GMP Inspection Approach online courses.
- Quality Systems Track
- Facilities and Equipment Systems Track
- Materials Systems Track
- Production Systems Track
- Packaging and Labeling Systems Track
- Laboratory Control Systems Track
- Compare all Tracks side-by-side (
33 KB)
Additional ISPE GMP Resources
Articles
- Just in Time: An Approach for a cGMP Fill-Finish
Facility (
5 MB) 
by Andrew Cunningham. This article presents a detailed narrative on the design drivers and
delivery methodology for Genentech’s recently completed fill-finish facility in Hillsboro, Oregon.
Pharmaceutical Engineering magazine, March/April 2010. - Pharmaceutical Manufacturing: Linking Vision and
Decision-Making to Achieve a Roadmap Toward cGMPs for the 21st Century ( 484 KB) by Beatrijs Van Liedekerke,
Ingrid Maes. This article presents the changing manufacturing environment and how companies can develop an
infrastructure to continue to meet their strategic objectives. Pharmaceutical Engineering magazine,
July/August 2007.
- Search for more GMP-related articles in Pharmaceutical Engineering magazine...
Books, Manuals, and Guidance Documents
Community of Practice
Mini Regulation Handbooks
- 21 CFR Part 11: Electronic Signatures
- 21 CFR Part 110: Food
- 21 CFR Part 111: Dietary Supplements
- 21 CFR Part 210 & 211: Pharmaceutical
- 21 CFR Part 608: Blood
- 21 CFR Part 820: Medical Devices
- ICH Q7A: API
- ICH Q8R2: Pharmaceutical Development
- ICH Q9: Quality Risk Management
- ICH Q10: Quality Systems
Online Courses and Webinars
- Industry Overview: Drug Dosage Forms
- Regulatory Compliance: Standards Practices and Guides
- Regulatory Compliance: Government Regulations
- Risk Management and Quality Management Systems (QMS)
Posters
Training Courses
- Applying the GMPs
- Auditing for GMP
- GMP Fundamentals for the Biotechnology Industry
- GMP Fundamentals for the Pharmaceutical Industry
- Q7A Essentials
Indicates content available to ISPE members only.
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