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Cleaning Validation Equipment Grouping

Created by: Fred Ohsiek, Cleaning Validation ExpertGrouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime.  Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.Common industry practice is to either avoid grouping because of perceived risk […]

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Stage 1: High-Potent Active Pharmaceutical Ingredient (HPAPI) Cleaning Validation (CV)

Created by: Fred Ohsiek, Cleaning Validation ExpertThis article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs; therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.It is important that the requirements for the finished manufacturing companies are […]

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Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]

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Improving Risk-Based Decision Effectiveness: A Case For Risk Decision Review Points (KDRPS) In the Quality Risk Management Process

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]

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Improving Risk-Based Decision Effectiveness: Determining The Level Of Formality

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST […]

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