As a GLP/GMP company, Tepnel operates a fully auditable Quality Management System ensuring premium service with full documentation and traceability. All stages of our service are audited including the study plan, operational activities, data analysis, data derivation, the draft and final reports. Our QA personnel are fully conversant with GLP/GCP regulations and provide an independent and fully accountable inspection ad auditing service.
We have been and continue to be inspected by the regulatory authorities from the UK (MHRA) and the USA (FDA) and we welcome inspections from our clients as part of their own supplier approval programs. Our own internal QA dept operates an independent of production self-inspection regime, ensuring that we continue to improve and maintain our high standards and compliance within an ever-evolving regulatory environment.
The principal elements of the Quality System include:
- Resource Planning
- Standard Operating Procedures to capture all processes
- Deviation CAPA system
- OOS Risk Assessment
- Change Control
- Training and Development of Staff including quality and regulatory elements
- Self-Inspection by an independent QA Dept.
- Evaluation and Analysis i.e. trends to continuously develop our systems and improve
The systems and processes in place and as captured in our documented procedures are designed to ensure that all operations are carried out by staff who are both well organised and trained to carry out work aware of their responsibilities to clients, Tepnel's and all relevant regulatory quality requirements.
