Deviations and CAPA
Clearing deviation and CAPA backlogs, and reviewing the processes that generate them, to return to a controlled flow for good.
FDA
Gap analysis against US requirements, support for pre-approval inspections (PAI) and FDA inspections.
Mock inspection: a dry-run inspection led by former FDA investigators, to put your teams in a real-life situation.
Lead expert: John Orsato
Risk management
Risk analysis of your processes and new facilities.
Non-compliance risks: a comprehensive analysis to identify and quantify all your risks.
Data integrity and computerised systems
What the agencies expect
Agency observations on computerised system validation (CSV) are rising: they now account for a quarter of all observations issued. Neglecting these systems exposes you to severe findings, particularly for major systems such as ERP, laboratory equipment and LIMS. Cyber risks are also receiving growing attention.
Binding standards: GMP, Annex 11, 21 CFR Part 11, ALCOA+ principles. Guidance: GAMP 5, ICH Q9.
Our approach
- audit based on your documents (validation master plan, qualification files) and on actual practice on the shop floor, against the standards;
- assessment of your risk analyses and of the depth of testing they require;
- consideration of cyber risks;
- prioritised action plan following the gap assessment, and follow-up of its implementation.
The most frequent gaps
What we have encountered most often over the past five years:
- shortcomings against ALCOA+ principles: poorly locked analytical methods, backup and restore that fail or have never been tested, no second-person verification in hybrid set-ups (paper and computerised system);
- complacent risk analyses that lead to edge cases not being tested;
- cyber risks that are poorly assessed and insufficiently covered.
Lead expert: JP Bovée
Visual inspection
Our experts support you on the visual inspection of your injectable products:
- defect selection and criticality classification;
- visual inspection qualification for manual, semi-automatic and automatic inspection;
- visual inspection qualification for clinical batches;
- difficult-to-inspect parenterals strategy;
- statistical control and trend analysis.
Lead expert: Jean-Michel Tasserit
Human error prevention
An original method for preventing human error, applied to production and quality control operations.
