TOTAL QUALITY & REGULATORY PROGRAMS
Operating a Stringent Quality & Regulatory Program
- Upholding Global Regulatory Requirements
- Testing to the Highest Quality Standards
- Applying Rigorous Oversight & Controls
Highlights Include:
- Global GMP Standards Meeting US-FDA, ICH Q7 & IPEC Guidelines
- Comprehensive Internal Auditing of all Manufacturing Processes
- Regulatory Services including Drug Master File Submissions
- FDA Process Validation for all GMP Manufacturing Systems
- Complete Testing of all Finished Manufactured Lots
- On-site Quality Control Labs Operating 24/7
- Robust Preventive Maintenance Program
- State-of-the-art Instrumentation
- FDA Registered & Inspected
- Raw Materials:
- Qualified and Inspected Sources
- 100% Authentic Traceability
- Complete Testing
Quality Assurance
- Validation of all GMP Manufacturing Systems
- Rigorous Preventive Maintenance Program
- Qualification of all Equipment
- Stringent Cleaning Protocols
- Environmental Monitoring
- Change Control Process
- Equipment IQ-OQ-PQ
- Document Control
Regulatory Control & Support
- Creation and Submission of Drug Master Files for APIs and Excipients
- Creation and Control of all Critical Documentation
- Management of all External Audits and Certifications
Quality Control
- Fully staffed, on-site Quality Control Laboratories
- Validation and Verification of all Test Methods
- Qualification of all Instrumentation including ICP-MS, GC-MS, HPLC, UV/Vis, TOC, Ion Chromatographer, Conductivity Meter, IR UATR, Polarimeter, Karl-Fisher Titrator & more
