Quality Management

cGMP and other higher industry quality standards are an integral part of the comprehensive quality system of DOTTIKON EXCLUSIVE SYNTHESIS AG's independent Quality Management department. 

DOTTIKON meets the high quality requirements of its customers thanks to the strict adherence to a quality system based on the process approach of ISO 9001:2008, which includes cGMP according to ICH Q7 as well as safety, health and environmental (SHE) protection.

 

DOTTIKON is authorized by Swissmedic (Swiss Agency for Therapeutic Products) to manufacture and sell active pharmaceutical ingredients (APIs) including liquid and solid dosage forms. It is subject to regular inspections by the Regional Medicines Inspectorate of North-Western Switzerland. The most recent audit was completed in April 2016.

 

The Quality Management system is based on a 3-level hierarchy

  1. Quality manual with 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 monitors compliance with cGMP requirements such as review of batch records. Activities such as cleaning 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 eCTD format and are registered with the respective authorities worldwide

  • In Europe with the EMA (European Medicines Agency) in the 'centralized procedure' and with the several national authorities in the 'national procedure'
  • In USA with FDA as Drug Master File Type II
  • In Japan with PMDA (Pharmaceutical and Medical Devices Agency)
  • In several other countries such as Australia, New Zealand and Canada

 

DOTTIKON's most recent FDA audit was completed in September 2015.

Quality ManagementQuality ManagementQuality Management

ISO

DOTTIKON EXCLUSIVE SYNTHESIS AG complies with the process approach of ISO 9001:2008.

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 9001:2008 took place in December 2015. The strict adherence to ISO 9001:2008, cGMP and SHE requirements allows DOTTIKON to consistently meet the high quality, safety and environmental requirements set by authorities and customers.


cGMP

DOTTIKON EXCLUSIVE SYNTHESIS AG is committed to the high cGMP (current Good Manufacturing Practice) standards. The last Swissmedic audit took place in April 2016.

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 audit was satisfactorily completed in April 2016. 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 9001:2008. Compliance with cGMP is ensured throug 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.


FDA

The last US Food and Drug Administration (FDA) audit was passed in September 2015.

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 and September 2015. The sixth and most recent inspection was a five-day routine surveillance inspection, focusing on adherence to Good Manufacturing Practices (GMPs).

 

Based on these FDA audits, 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.


Environment

DOTTIKON EXCLUSIVE SYNTHESIS AG's environmental protection policy is based on the Responsible Care® and Voluntary Climate Protection program.

As an experienced chemical manufacturer active in the area of Hazardous Reactions, we are convinced that exacting standards are required to protect both human life and nature. Responsible Care® is the chemical industry's global voluntary commitment to continuous improvement in safety, health and environmental performance. Its principles are followed by every employee for the protection of human beings, the environment and all production facilities. DOTTIKON joined the RC program of the Swiss Science Industries in 1992.

 

The company is aware that its industrial operations and activities can affect the environment. DOTTIKON's policy makes safety, health and environmental protection a top priority. DOTTIKON's aim is to minimize potential risk to the environment by applying the highest technical standards. Efforts in this regard include

 

  • Development of low-waste processes

  • In-house treatment of contaminated waste water with a specifically designed activated carbon adsorption process, followed by a final biological treatment in an external municipal waste water treatment plant

  • Incineration of toxic waste water incompatible with the activated carbon treatment

  • Incineration of waste in compliance with legal requirements in an on-site
    rotary kiln

  • Waste gas treatment in line with chemical, technical and legal requirements

  • Water, air and waste monitoring by a specialized in-house laboratory

 

 

 

Common blue (polyommatus icarus) at DOTTIKON site