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.
- Applying the GMPs
- GMP Auditing for the Pharmaceutical Industry
- GMP Fundamentals for the Pharmaceutical Industry
- Q7A: Implementing Good Manufacturing Practices
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
- 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
Books, Manuals, and Guidance Documents
Community of Practice
Join an ISPE community of practice to participate in discussions on specific topics with your peers. Learn more about Communities of Practice.
GMP 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