Whitepaper: EU GMP Draft Annex 1: Potential impact on cleaning and disinfection

CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.

Robust cleaning and disinfection programmes are needed to meet the required cleanroom microbial grades, prevent cross contamination and subsequent microbial contamination of products. Incidents of contaminated product entering the supply chain have occurred in the last eight years with devastating consequences in the UK, USE, France, Italy and South Africa. 

The manufacture of both human and veterinary medicines in the EU is governed by EudraLex Vol 4 Good Manufacturing Practice – “The rules governing medicinal products in the European Union”. Each country in Europe adopts this legislation into their own country’s specific legislation.