Anforderungen an Glas als Primärpackmittel aus regulatorischer SichtDr. Anne Deicke und Dr. Jochen Norwig Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn Quality Requirements for Glass Containers as Primary Packaging Material from the Regulatory Point of View Glass is a useful and important primary packaging material for pharmaceutical dosage forms as well as for active pharmaceutical substances (active pharmaceutical ingredients, APIs). In the stage of pharmaceutical development several tests have to be carried out in order to demonstrate the suitability of the material. Regulatory requirements on the quality of the container are summarised referring to the territory of the EU. Special focus is made to licensing of medicinal products for human use. Key words Entwicklung, pharmazeutische · Glas-Behältnisse, pharmazeutische · Primärverpackungen · Qualitätsanforderungen · Stabilitätstests · Unverträglichkeit · Zulassungsanforderungen |
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pharmind 2003, Nr. 09a, Seite 895
