For research projects requiring GLP compliance, Paragon is prepared in advance with available FDA & OECD GLP-compliant procedures and well-defined deliverables.
For biologics production requiring GMP-compliance, Paragon offers validated systems and processes which facilitate the delivery of bulk API and final drug product for Phase I/II clinical trials.
- Compliant with applicable regulatory requirements – 21CFR Parts 210 and 211 / ICH Q7A
- Dedicated project team – GMP-knowledgeable and experienced
- Utility and environmental monitoring
- Preventative maintenance and calibration program
- Ensuring validated systems and equipment are appropriately maintained and operating as defined
- Materials control
- Receipt, handling and shipping of raw materials and components, equipment, supplies and product
- Production and process control
- Master and batch production records, test methods, and labeling and package control
- Personnel training and qualification
- Continuous evaluation and improvement