EPiC has recently concluded a comprehensive two‑week onsite visit at a leading sterile product manufacturing facility in India, delivering a full holistic Gap Assessment against the requirements of EU GMP Annex 1 alongside an intensive GMP sterile products training programme. The assessment covered the Pharmaceutical Quality System (PQS), premises and cleanroom design, equipment and utilities, personnel practices, sterilisation including PUPSIT, aseptic , environmental and process monitoring, and Quality Control (QC) activities, each evaluated to ensure robust sterility assurance and contamination control throughout all stages of aseptic manufacture.
In parallel to the assessment, EPiC delivered a multiday training course tailored for operators with existing knowledge of aseptic processing. The programme blended informal, interactive lectures with practical exercises, team-based tasks, and operator qualification activities.
Delegates received pre‑read “Back to Basics” materials as a foundation, followed by two days of theory, one day of hands‑on practice sessions, and formal qualification assessments designed to evaluate operator capability against EU GMP Annex 1 expectations.
The onsite format enabled participants to link theoretical principles directly to their own processes, facilities, and contamination control strategies.
“Our goal was not just to identify gaps, but to build capability and confidence within the team,”
“The commitment shown by the operators and management to strengthening their Annex 1 compliance and sterility assurance culture was exceptional. This collaboration ensures sustainable improvements, not just short-term fixes.”
Darren Jones, EPiC Director and lead trainer.
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Get in touch with our team to arrange a customised Annex 1 assessment or training programme designed around your facility, your people, and your products.
Discover more about EPiC’s GxP GAP Assessment Services