Quality Assurance
Quality Assurance
Avéma is committed to providing you with the highest quality products at the lowest possible total cost. To achieve this, product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction are the foundation of our business processes.
Our quality assurance program includes:
Process design, testing and validation for all new products
Analysis of raw materials and quality assessments at every step of our manufacturing and packaging processes
Highly automated, advanced technology systems, which assure consistent manufacturing results
A highly trained and engaged workforce
Optical Character Recognition systems, which ensure data and lot tracking compliance
Vision Systems, which provide in-line identification and inspection
Video monitoring of processes, which provides completely traceable production
All products tested to confirm potency, uniformity and stability
Regulatory compliance with all regulatory organizations
Implemented ICH Guidance’s Q8, Q9, and Q10
Alignment with FDA’s Critical Path Initiative
FDA and DEA compliant
Design, Test & Verify
Quality is the cornerstone of Avéma Pharma Solutions. Our customers expect to receive a quality product from us — and the consumers that use the products we supply trust they are safe and effective.
Each employee at Avéma is a quality stakeholder in the manufacturing and packaging of all the products that we supply to the marketplace. We build a quality process at every stage, test its effectiveness and then verify its performance by adhering to, and even exceeding, rigorous FDA guidelines and cGMP compliance. Our highly trained team of professionals develop and validate laboratory methodologies, carefully monitor ongoing stability, and support the formulation and manufacturing process from development through commercialization.
Our disciplined approach to quality includes:
Validation: Master Validation Plan, Equipment IQ, OQ, PQ, Process,
Cleaning Validations, Facilities Monitoring
Master procedure documentation and control
Specifications development and management
Work flow control: receiving, production and shipping
Batch record development and documentation
CAPA Program (Corrective And Preventive Action)
Personnel Training Program with dedicated trainers
100% QA in-process verification
Rigorous management of change control
