Anwendung der Hazard Analysis and Critical Control Points-Risikoanalyse am Beispiel eines parenteralen Medizinproduktes
Klaus-Dieter Kühn a und Michael Jahnke b
Heraeus Kulzer GmbH & Co. KG, Wehrheim/Ts. a, und Pharma Hameln GmbH, Produktetablierung und Transferdokumentation, Hameln b
Application of Hazard Analysis and Critical Control Points Risk Analysis demonstrated with a Parenteral Medical Product
In order to guarantee the consistently high quality of medicinal products for human use it is absolutely necessary that flawless hygiene conditions are maintained through the strict observance of hygiene rules. With the grown understanding of the impact of process conditions on the quality of the resulting product, process controls (surveillance) gained increasing importance to complete the quality profile traditionally defined by post-process product testing. Today, process controls have become an important Good Manufacturing Practices (GMP) requirement for the pharmaceutical industry. However, before quality process controls are introduced, the manufacturing process has to be analyzed, with the focus on its critical quality-influencing steps. The HACCP ( Hazard Analysis and Critical Control Points) method is well recognized as a useful tool in the pharmaceutical industries risk analysis. This risk analysis, following the guidelines of the HACCP method and the monitoring of critical steps during the manufacture process was applied to the manufacture of methyl methacrylate solution used for bone cement and led to the establishment of a preventative monitoring system and constitutes an effective concept for quality assurance of hygiene and all other parameters influencing the quality of the product.
Key Words HACCP · Knochenzement · Medizinprodukt · Methylmethacrylat · Qualitätssicherung
pharmind 2002, Nr. 2, Seite 179