Aptuit is dedicated to maintaining the highest standard in the industry. Our Quality Assurance (QA) group ensures quality management, documentation and records, materials management, laboratory controls, and cGMP. We work closely with our clients' Quality Assurance staff to manage any GMP issues, audits, or any other potential issues during and after the project. Our QA team also supports any range of validation effort, including process validation, methods validation, and cleaning validations.
We ensure our facility operates to full cGMP, and our SOP systems are comprehensive, reaching every aspect of material flow. SOPs govern these activities:
- Material Arrival
- Generation of Master Production Records
- Generation of Specifications
- cGMP Manufacturing
- Cleaning Validation/Verification
- Packaging and Shipping of API