Areas covered
Aseptic filling
Freeze-drying
BFS-FFS
Single-use
Barrier technologies
Utilities
Media Fill Test
Environmental monitoring
Sterilisation
Personnel training
Three services
1. Gap analysis
Review of all or part of your quality system – procedures, records, deviations, qualification and validation reports, environmental data – to identify significant gaps and propose an action plan: training, investments, procedures.
2. Contamination control strategy (CCS)
Review of existing documents and data, identification of those to be created, and a proposed overall CCS structure, ready to be presented during an inspection.
3. On-site training
Training of your teams on all or part of Annex 1, as a complement to the gap analysis.