Quality Assurance - GMP
Quality Assurance (QA) and Quality Management (QM) are two subjects with a strong organizational and financial impact on the healthcare industries, from product design to production.
Medicines / Pharmaceutical expertise centre
Outsourced Activities & Supplier Audit
- Audit of subcontractors and suppliers API/RM/PM locally and abroad
- Audit of GMP service providers (Metrology, pest control ....)
- Creation or update of the supplier evaluation system
- Definition and management of the transfer
Management and Operational Quality Assurance
- Creation or compliance of the Quality System (CAPA management, anomalies, deviations, change control, customer complaint management)
- Product Quality Review (PQR): System implementation with statistical tools and software (Minitab, ....)
- Regulatory compliance: System implementation
Documentary management
- Creation or update of the documentation system.
- Creation or update of Standard operating procedures.
- Creation or update of instructions and operating modes.
Commissioning / Qualification
- Installation qualification.
- Operational qualification.
- Performance qualification (Premises and equipment).
Business Strategy Consulting
- Status report Diagnosis
- Remediation Plan
- Coaching
Quality Control Laboratory and Analytical Development
- Selection, development, and optimization of new analytical methods.
- Analytical Validation: System implementation and training.
- Conducting analytical validation and drafting files.
Analytical Validation and Process Validation
- Validation of manufacturing and packaging processes
- Cleaning validation
- Computer system validation
- Automatic System Validation
Medical Devices / Cosmetics / Food Supplements / Reagents
Implementation of a Quality System
- Creation or compliance of the Quality System
- Preparation of ISO certification (ISO 22716, ISO 9001, ISO 13485...)
Documentary management
- Creation or update of the documentary system, SOPs, instructions and operating modes