Conference paper
Quality Assurance and Standardisation of Patch Tests for Contact Allergens Skin Testing
Jurgen Brinkmann
Abstract
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.
Keywords
contact dermatitis; corporate culture; manufacturing process; patch test substances; pharmaceutical standard; pharmacokinetics; process validation; quality assurance system; regulatory authorities
Hrčak ID:
293
URI
Publication date:
14.6.2004.
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