Sterile practices reviewed against EU GMP Annex 1

The revised Annex 1 to the EU Guidelines to Good Manufacturing Practice, covering the manufacture of sterile medicinal products, became applicable on 25 August 2023. It formalises a risk-based approach to sterility assurance, placing the Contamination Control Strategy (CCS) at the centre of aseptic manufacture and drawing together facility design, cleanroom classification, personnel behaviour, environmental monitoring and process design into a single, documented framework. Ergopharm reviewed its sterile operations at the Ergopharm Advanced Research Centre in Vadodara against this text.

“Sterility assurance at Ergopharm is treated as a documented, risk-based system spanning facility, utilities and people, not as a single test at the end of the line.”

At the heart of Ergopharm's response is a formalised Contamination Control Strategy that maps each source of potential contamination on our sterile injectable lines to the controls that manage it. The strategy is anchored in the established EU/WHO GMP cleanroom grades A to D, with Grade A unidirectional airflow maintained at 0.36 to 0.54 m/s at the critical zone and mapped to the corresponding ISO 14644 classes. Purified Water and Water-for-Injection systems, HVAC and associated utilities are treated as integral elements of the strategy rather than as standalone services.

The review confirmed that qualification and validation evidence remains aligned with current expectations. Cleanroom and utility qualification follows the IQ/OQ/PQ sequence, and aseptic process performance is demonstrated through the three-stage process validation lifecycle, from design through process qualification to continued process verification. Environmental monitoring programmes, gowning qualification and aseptic process simulations were examined against the revised text, with data captured under ALCOA+ data-integrity principles and any gaps handled through Ergopharm's deviation, CAPA and change-control procedures.

Consistent with the wider ICH quality framework, the review was conducted within Ergopharm's pharmaceutical quality system in the spirit of ICH Q10, applying quality risk management as described in ICH Q9. Findings feed into the Product Quality Review cycle, and batch release remains subject to Qualified Person certification supported by the Batch Manufacturing Record and Certificate of Analysis. All figures cited here are illustrative of Ergopharm's own processes and do not represent any national marketing approval.