Good Manufacturing Practice (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.
GMP Resources
Training Options
Classroom Training
- Applying the GMPs
- GMP Auditing for the Pharmaceutical Industry
- GMP Fundamentals for the Pharmaceutical Industry
- Q7A: Implementing Good Manufacturing Practices
Online Training
USFDA'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
Online Webinars
- Industry Overview: Drug Dosage Forms
- Regulatory Compliance: Standards Practices and Guides
- Regulatory Compliance: Government Regulations
- Risk Management and Quality Management Systems (QMS)
Pharmaceutical Engineering Articles
iSpeak BlogThere is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development approach. Advanced therapy medicinal products are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit, based on a...
Books, Manuals, and Guidance Documents
Community of Practice
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