Zschaler R
Hauptabteilung Mikrobiologie des NATEC Instituts für naturwissenschaftlich-technische Dienste GmbH, Hamburg.
Zentralbl Bakteriol Mikrobiol Hyg B Umwelthyg Krankenhaushyg Arbeitshyg Prav Med. 1989 Apr;187(4-6):546-56.
The GMP-Rules, which were formulated by the WHO in 1969, were passed into German national lay by April 1st, 1985 as "Betriebsverordnung für pharmazeutische Unternehmer". The aim of this law is to guarantee constant quality of medical supplies. The food producing industry is facing similar requirements formulated either within the Codex Alimentarius or within the Code of Hygienic Practice of FDA (General Requirements for Food Manufacture). The degree of realization for these concepts of quality assurance however is varying extremely between different areas of food production. The requirements with regard to buildings, production plants, process technology, distribution and personnel hygiene as well as the principles of the HAAC-concept are described using examples from soft cheese, milk powder- and sweets industry.
世界卫生组织于1969年制定的《药品生产质量管理规范》于1985年4月1日作为“药品企业经营条例”成为德国国家法律。该法律的目的是确保医疗用品的质量稳定。食品生产行业面临着类似的要求，这些要求要么在《食品法典》中制定，要么在FDA的《卫生操作规范》（食品生产一般要求）中制定。然而，这些质量保证概念在不同食品生产领域的实现程度差异极大。通过软奶酪、奶粉和糖果行业的例子，描述了关于建筑、生产工厂、工艺技术、分销和人员卫生的要求以及危害分析与关键控制点（HAAC）概念的原则。
