The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464285.pdf
Content:
The ICH M7 Guideline discusses the derivation of Acceptable Intakes (AIs) for mutagenic impurities with positive carcinogenicity data, (Section 7.2.1) and states: “Compound-specific risk assessments to derive acceptable intakes should be applied instead of the TTC-based (Threshold of Toxicological Concern-based) acceptable intakes where sufficient carcinogenicity data exist.
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity