Product responsibility

GMP compliance 

In the pharmaceutical industry, product responsibility – in addition to system, work and transport reliability – is one of the essential principles of business activity. For this reason, we apply the highest quality standards and have made the quality management function a matter of our company’s top executive level. The integrity of the product matters, and therefore our customers have the highest expectations on the quality and performance of our services. We apply our entire know-how and  our state-of-the-art technologies to fully meet the customers’ expectations. At Rottendorf Pharma we unconditionally implement the increasingly complex regulatory requirements. Through our experienced Quality Assurance team we offer all required functions to always achieve full GMP compliance:

Regulatory support service

Supplier & contractor qualification

Regulatory inspections every year

Annual product quality review

Qualified Person release

Regulatory support service

Cleaning validation studies