Example of Item ‘Work Stations within a Grade C Clean Room' and Hazard ‘Contamination of Product by Bioburden on (Critical) Surfaces’ within the CCS Applying the HACCP Methodology
| 1. Source of contamination | Equipment |
| 2. Item | Work stations within grade C clean room |
| 3. Hazard identified that needs to be controlled | Contamination of product by bioburden on (critical) surfaces (surfaces that are directly in contact with air) |
| 4. Hazard applicable for (product category): | Terminally sterilized, aseptically manufactured, and other (nonsterile) products |
| 5. Critical Control Point (CCP) | Contamination / too high bioburden on (critical) surfaces. (Critical) surfaces should be suitable to be cleaned and disinfected (e.g., smooth surfaces) |
| 6. Limits | <25 CFU / plate (according to Annex 1) |
| 7. Method to control hazards | Cleaning and disinfection. In addition, validation of disinfection agents on specific material surfaces. |
| 8. Monitoring/testing | What (hazard/control): |
| Hazard: Bioburden on surfaces | |
| Control: Housekeeping inspection and Environmental Monitoring (EM) of the (critical) surfaces | |
| How: Settle plates and other EM data | |
| Frequency: Weekly EM | |
| Who: Operators from manufacturing department | |
| 9. Corrective action | Additional cleaning and/or disinfection, corrective maintenance, deviation procedure |
| 10. Verification | EM trends and QMS (e.g., TrackWise) review |
| 11. Record keeping | EM trends, deviations/investigations |
| 12. References | SOP for cleaning disinfection and EM, trend sheets |
| 13. Current state/residual risk | Green color (situation is under control) |
| 14. Justification/rationale/remarks | No justification or rationale provided (current state is green) |
CCP, Critical Control Point; CCS, Contamination Control Strategy; EM, environmental monitoring; HACCP, Hazard Analysis Critical Control Point; QMS, Quality Management System; SOP, standard operating procedure.