We ensure the high quality requirements of our customers by a quality system following the process approach of ISO 9001:2008, which includes cGMP according to ICH Q7 as well as Safety, Health and Environmental Protection (SHE) as an integral component.
DOTTIKON EXCLUSIVE SYNTHESIS is authorised 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 audit was satisfactorily completed in July 2009.
The quality management system is described in a 3-level hierarchy:
1.
The quality manual that gives a general overview and the perspectives of quality management.
2.
Processes and general instructions for the main business processes.
3.
Standard operating procedures with detailed description of each operational step.
As part of the company's quality management the quality control unit is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications.
The process analytics unit is responsible for in-process tests as well as release of cleaning results. The quality assurance unit controls the compliance with cGMP-requirements like review of batch records. Validation activities like cleaning validation and process validation are performed by the responsible quality management project manager.
Active Substance Master Files (ASMF) or Drug Master Files (DMF) are prepared in the new CTD format and are registered worldwide:
In Europe with EMEA (European Medicines Agency) in the 'centralized procedure' and with the several national authorities in the 'decentralized procedure'.
In USA with FDA as Drug Master File Type II
In Japan with PMDA (Pharmaceutical and Medical Devices Agency)
DOTTIKON ES' most recent audit by the US FDA was satisfactorily completed in October 2007.
