Developing an Effective Contamination Control Strategy

Abstract

Q A recent inspection of our facility resulted in several ?observations, including insufficient hand sanitization by personnel in the sterile filling area, deficient gowning in the microbiology laboratory, and use of wooden pallets in the cold storage area. In your case, the CCS should consider all the integral elements of sterile product manufacturing, including quality risk management (QRM) principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event) (2). Once you have performed this risk assessment, you will have sufficient information and data to understand, whether: * Your hand sanitizing procedures are adequate and effective * Your personnel training and personnel following procedures is correct * Your contamination control strategy for all points of risk of contamination from gloved hands is appropriate and sufficient.