Manufacturing and Quality Assurance

Manufacturing is a very challenging and changing environment in which AKKA supports its clients with specified projects or ongoing operations.

Our experts get involved on both the production side and the quality side to ensure compliance with GMP and FDA requirements. AKKA also provides support for continuous improvement by implementing lean processes.

AKKA Life Sciences is able to support its clients with:

• Planning and coordination of day to day production
• Continuous improvement
• Deviation support
• CAPA implementation
• Qualification and validation of process & equipment (performance qualification protocols, coordination and reports)
• Maintenance (preventive & curative) Quality Assurance support in GMP/GLP/GCP
• Audits, Continuous Improvement, Supplier Assessment
• QA Validation review
• QA GMP review (batch records, deviations, CAPA)
• Project management
• QA System
• Compliance

We can provide this support with experts on demand or on-site, seconded teams. These experts will respect the deadlines and constraints indicated by clients. When clients prefer a stronger partnership, they can also outsource the whole activity to AKKA.