Quality Management

In 1992, DOTTIKON decided to implement a Quality System according to ISO 9001. The subsequent project was successfully completed with the certification according to ISO 9001:1994 in 1994. ISO 9001 is a general quality system which is not especially designed for the chemical or pharmaceutical industry. It defines the framework and allows the company to define its own procedures within this framework. The advantage became even greater with ISO 9001:2000, DOTTIKON ES was able to integrate cGMP as well as safety, health and environmental (SHE) protection requirements into their ISO Quality Management System.

Within this integrated quality system, ISO has the benefit to cover all business areas of a company and to ensure effectiveness and efficiency throughout the whole organization. The most recent recertification according to ISO 9001:2015 took place in October 2021. The strict adherence to ISO 9001:2015, cGMP and SHE requirements allows DOTTIKON to consistently meet the high quality, safety and environmental requirements set by authorities and customers.

DOTTIKON is authorized by Swissmedic (Swiss Agency for Therapeutic Products) to manufacture and sell active pharmaceutical ingredients (APIs) including liquid and solid dosage forms based on regular inspections by the Regional Medicines Inspectorate of North-Western Switzerland.

The most recent inspection was satisfactorily completed in February 2022. This demonstrates that DOTTIKON is well in compliance with the current GMP regulations according to ICH Q7 (Eudralex, Vol. 4, Part II, PIC/S PE 009-12, Part II) as well as 21 CFR.

cGMP is an integral component of DOTTIKON's Quality System according to ISO 9001:2015. Compliance with cGMP is ensured through a Quality Management System that places special emphasis on equipment qualification and process validation including risk management.

Active Substance Master Files (ASMF) or Drug Master Files (DMF) are prepared in the eCTD format and are registered by the competent authorities worldwide. DOTTIKON is and remains committed to the high established cGMP quality standard and to developing it further in order to continue serving its customers as an approved supplier of products manufactured under cGMP requirements.

Registered products that are distributed to the US are subject to FDA approval. Part of the FDA's approval process are inspections to determine if the specific products, services and implemented systems are in compliance with the current Good Manufacturing Practices (cGMP).

In 1983 the FDA requested the Swiss Authorities to carry out an inspection at DOTTIKON on its behalf in accordance with the terms of the 1968 agreement between the US and Switzerland regarding the inspection of bulk pharmaceuticals.

DOTTIKON's first FDA inspection took place in May 1996 and was followed by subsequent inspections in June 1999, September 2004, October 2007, September 2012, September 2015, July 2017 and December 2022. The eighth and most recent inspection was a five-day routine surveillance inspection, focusing on adherence to Good Manufacturing Practices (GMPs).

Based on these FDA inspections, DOTTIKON has registered with the FDA as a facility for manufacturing active pharmaceutical ingredients. The respective registration number for the facility is FEI 3002806909 (DUNS 48 000 0413). In addition, the initial self-identification of the DOTTIKON site, as required by the Generic Drug User Fee Amendments since 2012 (GDUFA), has successfully passed validation and has also been accepted by the FDA.

DOTTIKON is committed to annually reconfirm the required FDA identification information and will do its utmost to make further improvements to keep up with any new requirements.