Use of the hazard analysis and critical control points (HACCP) risk assessment on a medical device for parenteral...

In order to guarantee the consistently high quality of medical products for human use, it is absolutely necessary that flawless hygiene conditions are maintained by the strict observance of hygiene rules. With the growing understanding of the impact of process conditions on the quality of the resulting product, process controls (surveillance) have gained increasing importance to complete the quality profile traditionally defined by post-process product testing. Today, process controls have become an important GMP requirement for the pharmaceutical industry. However, before quality process controls can be 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 industry. This risk analysis, following the guidelines of the HACCP method and the monitoring of critical steps during the manufacturing 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.