Pharmaceutical and food conformity

Systems and machines that are used in the processing of pharmaceutical products or food, or in general in hygienically critical environments, must meet certain criteria. At least for the food sector, these are defined in Europe:

EG1935/2004 – general regulations

The European Parliament issued Regulation EG1935/2004 on this in 2004. It replaces directives 80/590 / EEC and 89/109 / EEC. The purpose of this regulation is to protect consumers from health risks. It mainly relates to food, but in practice it is often transferred to other sensitive applications, such as the production of pharmaceutical products.

Materials that come into contact with food must therefore be manufactured in such a way that “under normal or foreseeable conditions of use, they do not release any components onto food in quantities that are able

  1. to endanger human health;
  2. to bring about an unacceptable change in the composition of the food;
  3. to cause an impairment of the organoleptic food properties (editor’s note: such as smell, taste, appearance, color, etc.). “

This also means that the labeling, advertising and presentation of the materials and objects must not mislead the consumer.

In addition to the general regulation, the EG1935 / 2004 contains information on individual measures, national individual measures, the approval of substances and labeling when they are placed on the market.

Conformity declaration

The materials and objects concerned must be accompanied by a written declaration that they comply with the applicable regulations. If necessary, it must be possible to prove this with suitable documents.

Traceability

In order to facilitate controls and the recall of defective products, the supply chains must be traceable through systems or processes.

Symbol für Lebensmittelkonformität

FDA food directive

The FDA Food Directive applies only to materials and devices brought into the United States. The FDA (Food and Drug Administration) is the authority responsible for the market surveillance of food, drugs and medical devices in the USA. Although it is of course not legally applicable in Europe, it does play a role for many European companies due to the importance of the American market. Of course, European companies in the USA have to adhere to the same guidelines as American companies.

The FDA specifies which devices, products, materials, etc. may come into contact with food and monitors compliance with the regulations. The same principle applies with regard to the criteria to be met as for EG1935/2004.

The NMPA (National Medical Product Administration) takes on the same role for China.

PTM Wiki

There is even more worth knowing in our PTM Wiki.

Please contact us:

If you would like to be advised on our products, our experts will gladly take care of your request:

 

info@ptm-mechatronics.com
Phone: +1 (850) 462-2730

Follow us on…

PTM mechatronics bei LinkedIn