PRIME HEALTH operation has a formal quality assurance program adhering to guidelines of current Good Manufacturing Practices (cGMP) 21 CFR part, 21 of the US Food & Drug Administration (FDA), , ISO/IEC-17025, OHSAS 18001:2007
Quality Assurance Procedures are strictly adhered to and followed by all laboratory personnel including executive management, lab administrators, managers, scientists and consultants.
The QA group routinely audits procedures and practices governing facilities, equipment, maintenance, instrument calibration, general lab procedures, client specific testing procedures, data reporting and data archiving.
Prime Health has developed more than 500 SOPs to meet the quality system requirements.
- Safety criteria
- Sampling and sampling techniques
- Sample storage, transport and disposal
- Product based testing
- Quality of consumables and reagents
- Use, maintenance and calibration of equipment
- Selection of test methods and method validation
- Measurement of degree of uncertainty for analytical techniques
- Document control
- Training
- Complaints handling
- Quality Risk Management
- Out of Specifications
- Investigation
- CAPA
- Self-Inspection
- Deviation Management
- Change Management
- Validations
- Quality Assurance procedures for different areas
- Reference Standard maintenance
- Calibration procedures and schedules
- Proficiency testing and Inter-laboratory comparisons
Prime Health believes to integrate total quality in every aspect of its operations – the focus being:
- Customer satisfaction
- Involvement of employees in quality improvement
- Maintenance of sample integrity
- Standardization of procedures
- Continuous training programmes for employees
- Continuous improvement through customer feedback
- Concentration on satisfying the internal clients
- Time Management
- Levelling Strategy for Utilization Resources