Less Than 1 Month Until Annex 1 Implementation – Are You Ready?

August 2, 2023 |


The new Annex 1 guidelines represent a significant evolution in regulatory thinking for the pharmaceutical industry. Emphasising global acceptance and implementation of ICH Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System), these updated guidelines call for a proactive approach to risk management and the integration of risk assessment into decision-making processes. With a strong focus on contamination control, cleanroom classification, and personnel controls, Annex 1 introduces new requirements to ensure the quality and safety of sterile and non-sterile manufacturing facilities. MCR Group’s experienced life sciences team is well-equipped to navigate these changes, offering expert guidance and solutions to achieve Annex 1 compliance.


Quality Risk Management (QRM) as a Proactive Tool

Annex 1 places great importance on using QRM proactively, emphasising its role in decision-making processes. MCR Group’s knowledgeable team incorporates risk assessment into all aspects of our service delivery, ensuring that potential challenges are identified and addressed before they become problems. By adopting a proactive approach, we help our clients stay ahead of regulatory requirements and industry trends.


Documented Contamination Control Strategy

The new Annex 1 calls for a documented and holistic contamination control strategy, customised for each manufacturing site and considering the entire manufacturing process. MCR Group works closely with clients to develop and maintain effective contamination control strategies, constantly reviewing, updating, and implementing improvements to reduce the risk of contamination.


Integration of QRM in Deviation Management

QRM plays a key role in deviation management, ensuring that quality is designed into every aspect of the manufacturing process. MCR Group’s expertise in risk management enables us to guide clients in incorporating QRM principles effectively, leading to more robust and compliant deviation management practices.


Cleanroom Classification and Personnel Controls

Annex 1 introduces additional cleanroom classification requirements beyond ISO standards. MCR Group assists clients in meeting these stringent requirements and ensures that personnel controls, including training, competency, and gowning procedures, are carefully implemented and followed.


Utilisation of RABS, Isolators, and Advanced Technologies

The use of Restricted Access Barrier Systems (RABS) and isolators is encouraged to enhance aseptic practices. Additionally, Annex 1 acknowledges the importance of rapid microbiological methods and new technologies. MCR Group advocates the adoption of scientifically sound technologies to ensure compliance with regulatory standards.


Inclusion of Non-Sterile Manufacturing Aspects

An essential feature of the new Annex 1 is its extension to cover aspects of non-sterile manufacturing, including low-bioburden facilities. MCR Group’s team possesses expertise in both sterile and non-sterile manufacturing, providing valuable insights and comprehensive solutions for compliance.


How MCR Group Can Help

At MCR Group, we understand the challenges presented by the new Annex 1 guidelines and are committed to assisting our clients in achieving compliance. Our experienced life sciences team focuses on risk assessment and contamination control in all service areas, enabling us to offer tailored solutions for each client’s unique requirements. By incorporating an effective training program focused on competence, proactive risk management, and quality by design, we ensure that our clients remain GMP compliant and audit-ready at all times. As industry leaders, we stay at the forefront of regulatory developments, utilising scientifically sound technologies and leveraging our quality team’s expertise to maintain regulatory adherence.



The new Annex 1 guidelines herald a transformative era in regulatory thinking, requiring pharmaceutical manufacturers to adopt a proactive and comprehensive approach to risk management and contamination control. MCR Group’s team of experts stands ready to assist clients in navigating these changes, providing industry-leading solutions and insights to achieve Annex 1 compliance successfully. Together, we embrace the challenges and opportunities presented by the new guidelines, forging a path towards safer and higher-quality pharmaceutical manufacturing practices.