A Clearer View of Annex 1

Helping You Manage Your Cleaning and Disinfection Challenges to Support Compliance

Annex 1 image

Ecolab has 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 minimize 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 fulfill 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.

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.

Learn More About Eudralex Vol. 4

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Life Sciences

Ecolab’s Life Sciences Division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical and personal care industries.

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