Creating an Annex 1-Compliant Contamination Control Strategy
By Gina Wynn
Controlling contamination in your facility is essential when producing pharmaceuticals that are unadulterated and safe for humans and animals. With the publication of new European Union regulations, production facilities in the United States and Canada will need to maintain compliance if they want to sell their products in EU countries.
In August 2022, the European Union Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use Annex 1 was revised. Manufacturers have until August 25, 2023, to fulfill the new minimum standards for manufacturing sterile medicinal products.
The Annex 1 revisions center around an infrastructural approach to Quality Risk Management (QRM) by establishing a detailed and extensive Contamination Control Strategy (CCS).
CCS Development Overview
If you don’t have a CCS in place to comply with Annex 1, you will need to establish and document a process to identify and assess risks in your facilities and define actions to prevent contamination of sterile products. This overview of what the process would involve is based on a recent MedTech Intelligence article.
Designate a Team
The first step in setting up a CCS is to designate a group of individuals who will be able to uphold and enforce standards consistently across your operation on an ongoing basis. It should represent technical knowledge of different departments, including production, engineering, maintenance, quality control, microbiology, and quality assurance.
To develop a strong strategy, the team should meet weekly for one to two hours for several months to discuss areas of risk in the facility and the manufacturing process, including equipment weaknesses. When not in meetings, team members serve as liaisons to other departments to explain contamination control requirements and identify high risk areas.
If you don’t have a CCS in place to comply with Annex 1, you will need to establish and document a process to identify and assess risks in your facilities and define actions to prevent contamination of sterile products.
Document the Policy
A formally documented contamination control policy is essential to meeting Annex 1 requirements. The document should outline how, when, and how often data will be collected and evaluated. It should cover the entire production process and will evolve over time as new data is gathered.
Additional local documents may be needed to identify critical areas to be monitored, including equipment operation, cleaning processes, and raw material storage and handling. The CCS should also define how often these documents should be updated and by whom.
Individual CCS team members should perform risk assessments according to their expertise to identify critical steps that could affect product quality. In some areas, multiple experts may be needed to assess risks. Checks for water purity, for example, would need to involve representatives from engineering, microbiology, and quality assurance.
The group will also need to devise control methods and establish monitoring systems that gather data about the proper functioning of equipment and processes. This data should be included in an overarching CCS document to enable comparisons over time. To comply with Annex 1, the global strategy and local activity must be re-evaluated every year to support continuous risk management.
Protect What Matters Most
By developing and maintaining a strict contamination control strategy according to the Annex 1 updates, you’ll increase confidence in the quality of your output, protect your products and people, maintain your relationship with EU customers, and potentially expand your business.
To view a comprehensive assortment of contamination control products that meet the specifications and requirements of your critical environment, visit fishersci.com/contamination-control. To find out how we can support your production process, visit fishersci.com/production.
Gina Wynn is a Thermo Fisher Scientific staff writer.