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FDA Current 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products
Origin/Publisher:
US Federal Register
Document Type:
Final Regulation
Content:
The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP)requirements applicable to combination products. This rule is intended to promote the public health by clarifying
which CGMP requirements apply when drugs, devices, and biological products are combined to create combination
products.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others