Canadian Pharmacist Qualifying Exam Practice · Question
According to Canadian Good Manufacturing Practices (GMP) for compounded sterile preparations, what is the maximum recommended beyond-use date for a low-risk sterile compound prepared in a laminar airflow workbench?
For low-risk compounded sterile preparations, the BUD is typically 48 hours at controlled room temperature and 7 days when refrigerated. This ensures microbial
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Question: According to Canadian Good Manufacturing Practices (GMP) for compounded sterile preparations, what is the maximum recommended beyond-use date for a low-risk sterile compound prepared in a laminar airflow workbench?
Answer options:
- 24 hours at room temperature, 3 days refrigerated
- 12 hours at room temperature, 48 hours refrigerated ✅ 48 hours at room temperature, 7 days refrigerated
- 7 days at room temperature, 14 days refrigerated
Correct answer: 48 hours at room temperature, 7 days refrigerated
Explanation: For low-risk compounded sterile preparations, the BUD is typically 48 hours at controlled room temperature and 7 days when refrigerated. This ensures microbial limits are maintained.
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