Example of Item ‘Glove Contamination’ as a Potential Source of Contamination within the CCS Applying the HACCP Methodology
| 1. Source of contamination | People |
| 2. Item | Glove contamination |
| 3. Hazard identified that needs to be controlled | Contamination of gloves |
| 4. Hazard applicable for (product category): | Terminally sterilized and aseptically produced products |
| 5. Critical Control Point (CCP) | Five fingers of glove from operator (which can be measured on contamination) |
| 6. Limits | Grade A area: <1 CFU/glove Grade B area: <5 CFU/glove |
| 7. Method to control hazards | Periodic hand disinfection |
| 8. Monitoring/testing | What (hazard/control): Hazard: print of five glove fingers |
| How: TSA agar print | |
| Frequency: during every production shift | |
| Who: Operators from manufacturing department | |
| 9. Corrective action | Go see, deviation, retraining, disqualification |
| 10. Verification | Initial (practical) training, clean room spot check (procedure), trend reports, hand disinfection procedure (read and understood) |
| 11. Record keeping | Local procedure/SOP within Quality Management System (QMS), which is used to report incident/data. Recording of fingerprint results within trend sheets/database. |
| 12. References | Local procedure/SOP within QMS that describes disinfection of gloves and how to perform a clean room spot check |
| 13. Current state / residual risk | Green color (situation is under control) |
| 14. Justification/rationale/remarks | No justification or rationale provided (current state is green) |
CCS, Contamination Control Strategy; HACCP, Hazard Analysis Critical Control Point; QMS, Quality Management System; SOP, standard operating procedure; TSA, tryptic soy agar.