Quality

Comprehensively certified

BODE Chemie develops, produces and distributes brands coming with reliable quality and great benefits for the user. Hence, each product – from application aid to patented chemical formulation – is subject to a complex management system meeting internationally accepted ISO standards.

As supplier of medicinal products, BODE strictly adheres to the German Medicines Act (Arzneimittelgesetz, AMG). Following this high quality demand, parts of the company’s medicinal product and cosmetics production far exceed the required quality standards.

Environmental aspects are integrated elements of BODE’s organisational and operational activities as well. Internal and external audits regularly monitor and evaluate the environmentally friendly operations of the enterprise.

Quality management at highest level

As GMP*-certified manufacturer of top-class medicinal products, BODE Chemie is geared to international quality and occupational health standards. All of the company’s operational processes – from development and production to the global distribution of our branded preparations – are subject to an integrated management system at highest international level. The certifications include the DIN EN ISO 9001 certification for introducing and maintaining a quality management system and the DIN EN ISO 13485 standard, which considers specific requirements for medical devices.

*GMP = Good Manufacturing Practice

GHS - Globally Harmonised System

Globally Harmonised System. Regulation (EC) No. 1272/2008, also referred to as GHS or CLP (Classification, Labelling and Packaging) regulation, stands for the global harmonisation of the classification and labelling of chemicals. This means the rules for hazardous substances and goods are transferred to one single new system. The CLP regulation replaces the previous EU Directive on dangerous substances (67/548/EEC) and the EU Dangerous Preparation Directive (1999/45/EC). The new classification and labelling includes new hazard pictograms, hazard statements (H phrases) and precautionary statements (P phrases).

The new GHS regulations entered into force on 20 January 2009. For mixtures, the transitional period continues until 1 June 2015.

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REACH

The European Community Regulation on chemicals (EC 1907/2006) entered into force on 1 June 2007. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. As EU regulation, it has equal and direct validity in all Member States. REACH harmonises and simplifies former legislation.

Please click here to see the current status.