Our Quality & Regulatory

At FCC, we work from a deeply rooted and proactive quality culture. Our high quality products are manufactured in compliance with cGMP, ICH and SHE regulations and standards. Teamwork by highly motivated, experienced and skilled experts is one of our key success factors. We all contribute as quality is at the heart of what we do.

Extremely high standards

Our compliance standards are extremely high. It is in our DNA to offer high quality APIs used for finished dosage forms that contribute to improving patients’ lives worldwide, meanwhile protecting our employees, the environment and our products. Our Quality Control Laboratories comply with ICH guidelines – particularly cGMP’s & ALCOA principles – and are capable of performing all testing in support of the product range.

Stringent controls

Our Quality Control Laboratories form an integral part of our cGMP manufacturing network. Stringent controls are applied for chemical starting materials, in-process controls and the extensive characterization of final products. We ensure quality APIs are manufactured in compliance with the relevant regulations and regulatory dossier such as, for example, US FDA DMF, CEP and J-DMF.

Successful audits

Our facilities are successfully inspected and approved by our customers and regulatory authorities such as the US FDA, EDQM and PMDA. Authorities and customers compliment us for excellence in implementing data integrity in the organization.

Our regulatory excellence

We have comprehensive regulatory experience in countries all over the world. We know, are involved, and act proactively on changes in monographs and on governmental regulations and expectations. Customers rely on our high quality dossiers and customer-oriented support and we provide assurance that their API project is in experienced hands.