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On site vaccine preparation: process, QC/QA |
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> Unblind pharmacist preparation – dispense final product |
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> Horizontal laminar flow hood |
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> Vaccine administration procedure |
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- Dispensed vaccine to dedicated coordinator to administer vaccine |
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Relabeling possibilities (expiry date) |
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> According to the local regulation – relabel should be carried out according to the GMP |
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> If authorized by the sponsor |
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> Action taken by two personnel |
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- One perform relabeling, one examine the correctness |
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> One perform relabeling, one examine the correctness |
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Accountability & tracking |
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> Standard accountability log record relevant container no. or lot no. |
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> Not destruct according to local regulation |
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> Return remaining IPs to sponsor according to institutional and sponsor’s SOP |
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Qualified person – registered institution pharmacist only |
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> GCP certification grant |
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> Individual protocol pharmacist training is mandatory |
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> Attend relevant conferences regarding clinical trials |
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Organization SOP is revised annual or when indicated |
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> Card-key controlled access |
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> Double lock practice |
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> CCTV is going to be implemented |
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