Article: Making Automation the Standard: An Annex 1 Overview

[Article Title]

The final version of the European Union (EU) good manufacturing practice (GMP) Annex 1 took effect in August 2023, advocating automated quality control (QC) technologies as a means of minimizing risk from microbial, particulate, and pyrogen contamination. Developers and makers of sterile pharmaceuticals can expect an array of new compliance challenges, not only in Europe but eventually in the United States.

Download the Document

    * denotes a required field

    Please fill out the information below. If you are already registered, and this information will be filled out for you.

  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the e-mail address you would like to be contacted at.

  • Please enter the phone number you would like to be contacted at.

    • By submitting this form, you consent to American Pharmaceutical Review storing your email address and contact information and transmitting your contact information to the content sponsor. You may request to be removed at any time.