Karen Rossington from Contec discusses how a new good manufacturing practice regulation is set to impact cleaning programmes within the pharmaceutical industry.
Cleanrooms
Cleaning and microbial contamination control are critical focus areas in the pharmaceutical industry. Robust cleaning and disinfection programmes are needed to meet the required cleanroom microbial grades, to prevent cross contamination and microbial contamination of products. Indeed incidents of contaminated products entering the supply chain with devastating consequences have happened in the last eight years.
The manufacture of medicines in the EU is governed by EudraLex Vol 4 Good Manufacturing Practice and each country in Europe takes the legislation into their own guidance.