Warning on transmissible Agents
Register now for ECA's GMP Newsletter
This guideline provides standard texts for warning statements on transmissible agents to be included, in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was adopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included.
Here you will get more information: "Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products".
Conference Recommendations
Related GMP News
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