Icoon FDA en GAMP

FDA and GAMP: assurance in pharmaceuticals and food

POWARE has worked with organisations in the pharmaceutical and food industries for many years. These sectors are subject to strict safety and quality requirements. If you export to the United States, for example, you must comply with the guidelines of the Food and Drug Administration (FDA). This means the operation of your automation system must be fully validated.

Working according to GAMP

Our consultants can help you do this. They work in line with the GAMP methodology: Good Automated Manufacturing Practice. This international standard is the foundation in the sector, ensuring that quality is not checked afterwards, but is built into every phase of the process. One of GAMP’s basic principles is that quality cannot be tested on a sampling basis. GAMP therefore focuses on all aspects of production: from raw materials, facilities and equipment to staff training and hygiene. The result is quality assurance that goes beyond the end product alone.

Assurance for audits and compliance

With POWARE, you bring in knowledge and experience. That gives you confidence for audits and compliance and makes it easier to demonstrably meet international requirements.

“POWARE, where people and technology strengthen one another.”