Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAI Annex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for […]
Presented by: Saurabh Joshi Shripad, Director for Solutions Engineering, ValGenesis, Inc. Ensuring the validated state of a cleaning process in an operational facility is complex, requiring a delicate balance of efficiency, compliance, and constant readiness. In this webinar, we’ll talk about how we can not only get this balance right but also make it even […]
Created by: Fred Ohsiek, Cleaning Validation Expert Grouping 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 […]
Created by: Fred Ohsiek, Cleaning Validation Expert This 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 […]
Created by: Matthew Jackson, Validation Manager, Torbay Pharmaceuticals This article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA. KENX-Insight_Matthew-Jackson_Cleaning-Validation-Program-Design_August-2022-1Download
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