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 […]

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 […]

Created by: Matthew Jackson, Validation Manager, Torbay PharmaceuticalsThis 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

Created by: Fred Ohsiek, Cleaning Validation ExpertDeveloping an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus on developing the automated CIP process for a new facility, but […]