After many years of discussion and much preparation, today is the day the revised Annex 1 takes effect, August 25, 2023. Have you reviewed the revisions, considered any gaps in your organization’s operations, and developed action plans to mitigate or remediate those gaps? Do you have a complete view of your firm’s compliance with the revised Annex 1? If not, you may need to consider urgent action… read on.

Perhaps the EU Good Manufacturing Practices (GMPs) are not often on your agenda, but you might want to take a closer look at the Annex 1 revisions. Agencies worldwide are aligned with these requirements, not to mention if you manufacture anywhere around the world and distribute your products in Europe, you will have to meet the Annex 1 standards.

Here are some of the key areas in the revised Annex 1:

  • Aseptic manufacturing: The revised Annex 1 provides very detailed guidance on aseptic manufacturing. The revised Annex 1 emphasizes the importance of a documented contamination control strategy and of training employees on aseptic techniques.
  • Pharmaceutical Quality System (PQS): The PQS should cover the specific requirements for the manufacture of sterile products. This means that the PQS should cover the facilities, equipment and utilities, people, specific requirements of production systems used (e.g., lyphilization and form-fill-seal), environmental conditions, and Quality control, and ensure that effective controls are in place for all activities.
  • Process validation and verification: The revised Annex 1 places emphasis on process validation and verification. This means that manufacturers should validate their manufacturing processes to ensure that they are capable of consistently producing products that meet their quality standards. They should also verify their processes on a regular basis to ensure that they continue to be effective.
  • Lyophilizers: The revised Annex 1 includes requirements for lyophilizers. The revised Annex 1 requires that lyophilizers be designed and operated in a way that minimizes the risk of contamination.
  • Cleaning and disinfection: The revised Annex 1 updates the requirements for cleaning and disinfection. The revised Annex 1 emphasizes the importance of using validated cleaning and disinfection procedures.
  • Documentation and recordkeeping: The revised Annex 1 includes requirements for documentation and recordkeeping. The revised Annex 1 requires that manufacturers maintain accurate and complete records to demonstrate that their products meet their quality standards.
  • Risk-based approach: The revised Annex 1 emphasizes the need for an effective and integrated risk management system that aims to minimize microbial contamination. This means that manufacturers should identify and assess the risks to the quality and safety of their products throughout the lifecycle of the product and then implement controls to mitigate those risks.


Stay tuned for more from Lachman Consultants, including informative webinars on the Annex 1 revisions in the coming months. Did you know that we have a proprietary Annex 1 audit tool? Our process can help you identify gaps, determine your levels of risk, and recommend CAPAs and remediations. Contact us today if you’d like to learn more.