Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
Attachment No.: QAS-002
Revision No.:
Issued on:
Initiator Name:
COMPLAINT CLASSIFICATION FORM
Class I : CRITICAL
Product defects that would result in serious, adverse health consequences or death
1. Active ingredient missing
2. Incorrect dosing of active ingredient that might result in serious adverse health
consequences or death
3. Product decomposition that might result in serious, adverse health conse-
quences or death
4. Changes in packaging components that might result in serious, adverse health
consequences or death
5. Change in active ingredient release that might result in serious, adverse health
consequences or death
6. Unexplainable changes in effectiveness that might result in serious, adverse
health consequences or death
7. Misbranding mislabeling or misprints that might result in serious adverse
health consequences or death
8. Counterfeit
9. Any other :
Class II: MAJOR
Product defects which will cause no adverse health consequences but will impair efficacy.
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