In the November edition of Clean Air and Containment Review Solmaz, General Manager of Lighthouse EMEA published a very informative overview regarding the creation, implementation and maintaining of monitoring plan based on Risk Assessment
Clean areas used for aseptic manufacturing of sterile medicinal products are subject to standards and guidelines to ensure quality of production and to minimize risks of particulate and microbiological contamination. In recent years, a proper monitoring plan with a risk-based approach has become a part of many standards and regulations such as ISO 14644-2:2015 and ICH Harmonized Guideline ICHQ9 Quality Risk Management. However it is also obvious that there is a lack of good application practices for proper monitoring plans that are based on risk assessment. This study provides information with an example of how to prepare a risk based monitoring plan incorporating risk assessment tools, current standards, regulations and guidelines.
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