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