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