QUALITY & COMPLIANCE

Our quality control approach encompasses every stage of the manufacturing process, from inspection of incoming materials and in-process control samples, through to product release and ongoing stability testing of finished products. We test all medicinal products, medical devices, food/dietary supplements, and raw materials against their specifications according to national and international laws and regulations. We also analyse our primary and secondary packaging materials for quality and conformity with specifications, as well as all patient leaflets for completeness and readability.

We work according to GMP (Good Manufacturing Practices) for medicinal products, international standards for food safety, such as HACCP (Hazard Analysis Critical Control Point) and US-CFR (Code of Federal Regulations), and ISO 13485 for medical devices. Our standards are regularly verified through audits by clients and international authorities. We have a dedicated team of in-house experts that regularly qualify and verify:

• Manufacturing processes and equipment.
• IT systems and infrastructure.
• Analytical equipment, processes, and methods.
• Cleaning procedures.
• Personnel training

MaxiPharma quality plan documents company’s quality goals, standards, practices, resources, specification, and procedures are in place.

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