Excerpt of ProJect Pharmaceutics’ Quality Management System (QMS):
- Based on the guidelines for pharmaceutical development of the International Conference on Harmonization (ICH)
- Based on the “Good practices for research and development facilities” guidelines of the World Health Organization (WHO), Nov. 2020
- Based on the requirements of ISO certification:
- Organigram, Responsibilities and Authorization, Technical Equipment, Analytical Methods, Map of Processes, Matrix of Communication
- SOP (Standard Operating Procedures) system for i.a. analytical methods, qualification and maintenance of technical equipment, processes, documentation
- Regularly maintained and calibrated measuring systems
- Qualified test methods and Pharmacopoeia methods
- Certified excipients
- Quality-by-design (QbD) approaches
- Electronic lab journals
- Long-term data storage (central and external server, backed up daily)
- Alarm circuits
- Staff qualification & continuous staff training
- Complies with GLP-like quality standards (standards for non-clinical R&D)
- No GMP required
- Documentation complies with standards for submission to authorities
- Design of experiment (DoE, protocol)
- Execution of task (raw data + evaluation)
- Documentation (electronic lab journal)
- Detailed final development report (“four-eyes principle”): Materials, methods, experimental design, results and conclusions described in detail. All raw data stored properly and provided on demand.