Across
- 1. The ICH guideline that governs stability testing
- 4. Analytical technique often used for purity testing
- 9. A test used to detect chemical residues after cleaning
- 10. A type of air filtration used in cleanrooms
- 11. A structured approach to identifying and mitigating risks in manufacturing
Down
- 2. The principle that data must be recorded at the time of generation
- 3. A regulatory inspection outcome indicating serious GMP violations
- 5. The process of ensuring a computerized system meets intended use and regulatory requirements
- 6. An application used to manage and track quality events, often digital
- 7. Study performed to ensure the drug remains within specs over time
- 8. A term for microbial contamination introduced during processing
- 12. The procedure of selecting representative units/items for testing