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)

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.