Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is understood to be the guidelines for the quality assurance of manufacturing processes and the manufacturing environment for the production of pharmaceuticals, active ingredients and medicines, but also for foodstuffs and fodder. A GMP-compatible quality management system guarantees the product quality and compliance with the requirements of the health authorities compulsory for marketing purposes. The corresponding guidelines for the pharmaceuticals sector are for example laid down by the European Commission, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), the US-American FDA and on a global level by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In the USA the guidelines of the ?Current Good Manufacturing Practice? (cGMP) apply, the small ?c? denotes the difference between the USA and Europe: In contrast to Europe, these guidelines are renewed every year by the USA. There is no uniform logo for the GMP certification, often the certified companies usually integrate claims such as ?certified according to GMP? into their company logos/slogans. http://ec.europa.eu/enterprise/pharmaceuticals/


Oeko-Tex Standard 100

The Oeko-Tex? Standard 100 is one of the independent inspection institutes of the harmful substance tests carried out by the International Oeko-Tex? Community. It was developed as a reaction to the consumers? needs for textiles that are not harmful to health. The Austrian textile research institute, (?TI) and the German Hohenstein Research Institute developed testing standards in 1992 based on their testing norms that had already been developed at the time. The Oeko-Tex? criteria catalogue provides the companies of the textile and clothing industry with a uniform benchmark for the assessment of possible problematic substances in textiles in the face of the globally organised and labourintensive textile production for the first time. The Oeko-Tex? label signalises to the end consumers the added benefit of safety-tested clothes and other textile products that are kind to the skin. The Oeko-Tex? system encompasses the following elements:

? worldwide uniform textile and human ecologically-
relevant testing criteria
? the annual re-evaluation and further development of the
established threshold values and criteria
? the testing and certification of the textile products by independent
testing institutes
? the testing of textile raw, intermediate and finished products in all
stages of the processing
? product conformity via internal quality management within the
companies
? product monitoring in the form of regular quality controls on the
market and at site visits by independent auditors of the Oeko-
Tex? Commuinty

Before textile products can be decorated with the Oeko-Tex? Label, all the components including accessories have to correspond without exception to the requirements of the criteria catalogue. This is verified by the Oeko-Tex? Certificate. The Oeko-Tex? certificate, which is issued by the commissioned institute or by the responsible certification body, is valid for 12 months.
www.oeko-tex.com