Biomedical Engineering Reference
In-Depth Information
Illustrative production observations that will
be escalated
Table 2.1
1. Deviation from an SOP
2. Foreign matter
3. Processing issues that result in segregating and destruction
of product
4. Non-adherence to specifi ed time limits for a processing step
5. Temperature, humidity, and/or pressure excursions during batch
processing
6. Product attribute defect issues
7. Raw materials found damaged during inspection
8. Contaminated product
9. Out-of-calibration results for GxP instruments
10. Use of non-calibrated GMP equipment
11. Use of non-qualifi ed GMP equipment
12. Missing data
13. Rejected materials not properly identifi ed and controlled
14. Use of an incorrect form to record GMP activity
Table 2.2
Illustrative lab observations that will be escalated
1. Deviation from an SOP
2. Out-of-Spec (OOS) test results
3. Microbiological cleaning failures
4. Incorrectly labeled samples
5. Error in stability samples for testing
6. Identifi cation of an adverse stability trend
7. Use of non-calibrated GMP equipment
8. Use of non-qualifi ed GMP equipment
9. Missing data
10. Use of an incorrect form to record GMP activity
be triaged, typically because they are not GMP issues, as
displayed in Table 2.3.
In any case, the observations (events) that are escalated will
