Solution

A clearer view of Annex 1

Helping you manage your cleaning and disinfection challenges to support compliance.


Solution

Ecolab have the experience to provide insight into the latest updates


* Annex 1, Draft v.12 of February 2020 includes five key areas that pharmaceutical manufacturers will need to be aware of that relate to cleaning and disinfection at their sites:

  • Clear distinction between cleaning and disinfection steps
  • Sterile products - consideration for use in both sterile and non-sterile areas
  • Ready-to-use product - to minimise additional controls with preparation, validation and expiry
  • Validation - to support the performance and in use application
  • Emphasis on Risk Management & Quality Management Systems (QMS)

Ecolab Life Sciences can help you fulfil these requirements.

Eudralex Vol 4

*EudraLex vol 4 covers Good Manufacturing Practice (GMP) guidelines and contains a series of Annexes (including Annex 1) that provide specific guidance on different aspects of medicinal product manufacture.

Why has it been updated?

Following the first round of targeted consultations, significant modifications were proposed and have been incorporated into the latest draft for a final period of consultation.

Contact Us

With unparalleled expertise and cutting-edge technology, we partner with customers to deliver world-class results and optimized operations.

Contact us to learn how we can help you.

WORLDWIDE HEADQUARTERS

1 Ecolab Place
St. Paul, MN 55102
USA

EUROPE HEADQUARTERS

Richtistr. 7
8304 Wallisellen
Switzerland
Contact us form