Quality assurance and standardisation of patch tests for contact allergens skin testing.
The misbranding of raw materials used in the manufacturing of patch tests and the counterfeiting of the final product of these test materials have gained increasing importance in the last decade with respect to the production process in the pharmaceutical industry. To guarantee the performance and safety of a semi-solid pharmaceutical testing form, it is important to make oneself acquainted with the different quality standards and official requirements demanded by the national and international regulations. Moreover it will be necessary to get an idea about the major factors which influence the quality of patch tests and therefore finally the quality of the medical allergic diagnosis.
Brinkmann
Jürgen
J
brial allergen GmbH, Greven, Germany. jbrinkmann@brial.com
D000485:Allergens; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis*; D004345:Drug Industry / Q000592:standards; D005062:European Union; D006801:Humans; D010328:Patch Tests / Q000592:standards*; D011786:Quality Control
D000485:Allergens