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.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
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. 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
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 111: Dietary Supplements
- 21 CFR Part 210 & 211: Pharmaceutical
- ICH Q7A: Active Pharmaceutical Ingredients
- ICH Q8R2: Pharmaceutical Development
- ICH Q9: Quality Risk Management
- ICH Q10: Quality Systems
- ICH Q11: Development and Manufacture of Drug Substances
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)
Tidak ada komentar:
Posting Komentar