EU GMP Annex 1 and the Contamination Control Strategy

What you'll be able to do

• ✓ Explain Annex 1 structure, scope and key changes
• ✓ Write and maintain a contamination control strategy
• ✓ Apply QRM to premises, barrier technology and gloves
• ✓ Control utilities, equipment and personnel as Annex 1 expects
• ✓ Apply sterilisation, PUPSIT, APS and container closure requirements
• ✓ Run an Annex 1 gap assessment

Syllabus

1. MODULE 1FoundationsAnnex 1 overview and the CCS.

   • Annex 1 (2022): scope, structure and what changedFree preview
   • The contamination control strategy (CCS)Free preview
2. MODULE 2Facility, utilities and peoplePremises, barrier technology, utilities and personnel.

   • Risk management, premises and barrier technology
   • Utilities and equipment
   • Personnel: training, gowning and behaviour
3. MODULE 3Process, monitoring and complianceProduction, monitoring, QC and gap assessment.

   • Production: sterilisation, filtration and aseptic processing
   • Environmental and process monitoring, and QC
   • Running a gap assessment, with case studies
   • Final exam (25 questions)

Questions