Structuring your contamination control strategy

BY DR TIM SANDLE  |  6 JANUARY 2023

A contamination control strategy (CCS) is a system that considers all the integral elements of pharmaceutical product manufacturing. A CCS should cover:

• Microbial contamination
• Cleaning and disinfection
• Sterility assurance
• Facility design
• Chemical and particle contamination
• Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations

The need for a CCS forms a core part of the revision to EU GMP Annex 1 however its easy to feel cautious when creating a CSS for the first time. In this blog we look at how developing the strategy might be approached, with due care taken in regards to how it is pieced together by the right personnel in possession of the relevant education, experience and technical knowledge.