Describe requirements of a well-designed Master Formulation Record template |
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Assess drug monographs and certificates of analysis |
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Comply with drug strength, pH, isotonicity, chemical sensitivity, chemical compatibility and container-closure requirements |
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Use formula ingredients, technique and technology as indicated in a preparatory procedure |
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Apply, and comply with combinatorial methods of filtration and sterilization to reduce preparation pyro-, and bio- burden |
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Explain beyond-use date time frames, storage, shipping and transportation requirements |
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Recognize visual inspection criteria and some procedures (e.g., sterilization method) on the basis formula composition |
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Relate sterility and bacterial endotoxin test methods to preparation quality |
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Describe inspection procedures integrating, the compounding record, label and compounded sterile preparation |
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