Quality Assurance: Between Compliance and Performance

Quality Assurance: ensuring excellence and compliance in your production

In the pharmaceutical industry, quality is a key issue that directly impacts the safety and efficacy of medicines. Faced with strict GMP, BPF, Annex 1 and NDA regulations, projects require in-depth knowledge of quality standards.

With an average of 13 years of experience, our consultants bring their expertise in quality processes to ensure that equipment, systems and processes comply with specifications and regulatory standards.

A QUALITY APPROACH INTEGRATED INTO EVERY PHASE OF THE PROJECT

Our teams are involved at every stage to ensure a smooth transition between projects, production and support services:
✔ Design and coordination of quality activities,
✔ Equipment, system and process qualification,
✔ Handling of discrepancies, anomalies and deviation management,
✔ Validation of cleaning and processes,
✔ Preparation of production authorisations.

We work collaboratively with your teams to strengthen your quality processes and secure your production.

OUR AREAS OF EXPERTISE IN QUALITY ASSURANCE

• QA Project Manager
• Responsible for operational quality assurance (CAPA, deviations),
• Quality indicator management and action plans,
• Process and cleaning validation,
• Computerised system validation.
• Qualification of production and packaging equipment,
• Qualification of premises, HVAC and utilities.
• System, product, supplier and customer quality.
• Data integrity,
• Support for audits and inspections,
• Metrology and control of production environments.

📢 Need expert support in Quality Assurance? Contact us now to secure your processes and guarantee the compliance of your production!