COMPLIANCE AND QUALITY ASSURANCE
The compliance office ensures that the CRI meets the rigorous standards set forth by the FDA for our drug manufacturing campaigns, pharmacological/toxicological animal studies, Phase 1 clinical studies and preparation of investigational new drug applications (INDAs). Staff members perform internal audits of all studies and campaigns to verify adherence to approved policies and procedures.
Duties include:
- Overseeing SOP creation and management
- Document management of lab notebooks and batch/manufacturing records
- Ensuring that CRI equipment and facilities are properly maintained, calibrated and in good working order
- Monitoring temperature, pressure, humidity, non-viable particles and microbial bioburden of clean rooms within the two drug manufacturing suites
- Keeping up-to-date inventories and certificates of analysis for all reagents, supplies, containers, closures, components and labeling components
Training records of employee education and training are also maintained by the compliance office.
RELEVANT FDA REGULATIONS
Also available at www.fda.gov
21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR Part 50 Protection of Human Subjects
21 CFR Part 54 Financial Disclosure by Clinical Investigators
21 CFR Part 56 Institutional Review Boards
21 CFR Part 58 Good Laboratory Practice
21 CFR Part 210-211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 312 Investigational New Drug Application
21 CFR Part 600 Biological Products
21 CFR Part 610 General Biological Standards
Guidance for Industry- CGMP for Phase 1 Investigation Drugs
Guidance for Industry- Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients