Is your Environmental Monitoring Annex 1 Compliant?

As the clock ticks down to the 25th August 2023, when the latest revision of EU GMP Annex 1 takes effect, we are reflecting on the impact of those changes to our customer’s Environmental Monitoring Systems, and how Pharmagraph can enable them to maintain compliance.

After 14 years of development, the revised requirements govern the manufacturing of sterile drugs made in the EU, as well as imported products. The Annex has been revised to “reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines.” *

The final revision of Annex 1 represents an extensive rewrite of the original 2008 version, with a page count increase from 16 to 58. The Annex includes sections covering scope, principles, pharmaceutical quality system (PQS), premises, equipment, utilities, personnel, production and specific technologies, environmental and process monitoring, and quality control.

The new version places a strong focus on risk management and having an overall contamination control strategy (CCS). Furthermore, the CCS should directly influence the environmental monitoring programme deployed and the associated data collected plays a key role. Ongoing monitoring data should be reviewed to identify any adverse trends in system performance.

Alongside the overall CCS, another area of particular concern are the new requirements to ensure that particle count tube length should be no longer than 1m unless justified, and the number of bends should be minimized.

To assist our customers in achieving Annex 1 readiness Pharmagraph are offering an Annex 1 Site Survey by one of our expert EMS engineers. This survey covers a documented procedure which reviews both key hardware and software status with the findings and key risk areas published in a summary report within 5 days of visit.

For more information or to book an Annex 1 Site Survey please contact our sales team via sales@pharmagraph.co.uk

*The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

Annex 1 - Manufacture of Sterile Medicinal Products