The new GMP Annex 1, which came into effect on August 25, 2023, introduces a number of significant changes from the previous version.

The revised Annex 1 places a greater emphasis on risk assessment and mitigation, quality risk management (QRM), and human factors. It also includes more detailed requirements for the monitoring, validation, and verification of critical manufacturing steps.

Here are some of the key changes in the new Annex 1:

  • Comprehensive Contamination Control Strategy (CCS): The new Annex 1 requires manufacturers to develop a comprehensive CCS that identifies, assesses, and mitigates contamination risks throughout the entire manufacturing lifecycle. This holistic approach ensures that every aspect of production – from raw material procurement to finished product packaging – adheres to stringent microbial control measures.
  • Pharmaceutical Quality System (PQS): The PQS is a comprehensive framework that integrates all aspects of pharmaceutical manufacturing. The new Annex 1 emphasizes the importance of the PQS in ensuring that all manufacturing processes operate in harmony with stringent quality standards. This seamless interconnected system eliminates silos and fosters a cohesive environment where quality is paramount.
  • Quality Risk Management (QRM): QRM is a systematic approach to risk assessment and mitigation. The new Annex 1 empowers manufacturers to proactively identify and address potential risks to patient safety. By meticulously assessing risks at every stage of the manufacturing process, the likelihood of producing unsafe products is significantly reduced.
  • Enhanced Monitoring, Validation, and Verification: The new Annex 1 significantly enhances the monitoring, validation, and verification of critical manufacturing steps. By meticulously documenting and analyzing these critical processes, manufacturers gain invaluable insights into product consistency and identify areas for improvement. This meticulous scrutiny translates into enhanced product quality and patient safety.
  • Emphasis on Human Factors: The new Annex 1 recognizes the profound impact of human factors on product quality. By emphasizing human error prevention and ergonomic design, manufacturers can create a safer and more productive work environment, contributing to the production of high-quality, patient-centric products.

Benefits of the New GMP Annex 1

The new GMP Annex 1 is expected to have a number of benefits for patients, including:

  • Reduced risk of contamination: The new Annex 1’s emphasis on risk assessment and mitigation will help to reduce the risk of contamination in sterile medicinal products. This will make it less likely that patients will experience adverse health effects from contaminated products.
  • Improved consistency of product quality: The new Annex 1’s emphasis on the PQS and QRM will help to ensure that all sterile medicinal products are manufactured to the same high standards. This will make it less likely that there will be differences in the quality of products from different manufacturers.
  • Enhanced patient safety: The new GMP Annex 1’s overall aim is to enhance patient safety. By reducing the risk of contamination and improving the consistency of product quality, the new Annex 1 is expected to help to protect the health of patients worldwide.


The new GMP Annex 1 is a significant step forward in pursuing sterile pharmaceutical excellence. By implementing the rigorous requirements of the new Annex 1, manufacturers can significantly reduce the risk of contamination, improve the consistency of product quality, and safeguard the health and well-being of their patients.