What Goes Wrong During Inspections?
- A leaky contamination control system —a single undetected particle can contaminate your entire batch.
- Inadequate Environmental Monitoring (EM)— lacking real-time insight means deviations go unnoticed until it’s too late.
- Missing or incorrect risk assessment— inspectors expect you to both identify and manage risks.
And that’s not all.
What about contamination control? Is your environmental monitoring airtight? And are you prepared for inspections where PUPSIT is a mandatory topic of discussion?
Without a rigorous risk assessment and continuous validation, you’re operating with an open-ended situation. Inspectors are masters at finding those loose ends.
That’s how you become fully inspection-proof
Step 1. Watertight SOPs and WIs
Write clear and detailed instructions that leave absolutely no room for interpretation. It’s important that employees understand why they need to perform certain tasks.
Step 2. Process validation
Consistent evidence that your processes deliver what they promise, every single time.
Step 3. Quality Systems
All documents must be fully traceable.
Start with a thorough analysis of your processes. Ensure that documentation is not a weakness, but a strength. Work on continuous risk assessment, contamination control, and smart process improvement to achieve an even more robust process.
Are you running into any issues related to Annex 1? Would you like to speak with a specialist? Call us directly at +31(0)20 751 20 12.
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