Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attach. No.: QAS-002
Revision No.:
Issued on:
Initiator Name:
Complaint
1. Inactive ingredients
2. Nonpathogenic microorganisms in excess of tolerance limits
3. Excessive amounts of physiologically harmless materials
4. Major and perceptible changes in appearance, odor, taste, physical/
technological properties, etc. of the product
#
5. Major changes and deviations in packaging components
#
6. Misbranding, mislabeling, or misprints of major proportions
(e.g., expiry date missing)
#
7. Product defect that would impair usability (e.g., broken tablets)
8. Defects in packaging components that would impair usability
(e.g., leaks, functional defects)
9. Missing labels
10. Empty packages
11. Underfiling, in terms of volume, weight, or quantity and overweight*
12. Commercial product with sample product identification
13. Labels peeled off, missing inserts*
14. Any other:
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