1. Personnel are appropriately trained and are capable of performing and qualified to perform their assigned duties. Such training should be documented.
2. Compounding ingredients of the appropriate identity, purity, and quality are purchased from reliable sources and are properly stored according to manufacurer specifications orUSP standards
3. Bulk component comtainers are labeled with appropriate OSHA hazard communication labels and Material Safety Data Sheets are available to compoundering personnel for all drugs and chemicals used in compounding.
4. All equipment used in compounding is clean, properly maintained, and used appropriately.
5. The compounding enviroment is suitable for its intended purpose; and procedures are implemented to prevent cross-contamination, espcially when compounding with drugs that require special precautions.
6. Only authorized personnel are allowed in the immediate vicint of the drug compounding operations.
7. There is assurance that processes are always carried out as intended or specified and are reproducible.
8. Compounding condtions and procedures are adequate for preventing errors.
9. All aspects of compounding are appropriately documented.
10. Adequate procedures and records exist for investigating and correcting failures or problems in compounding, testing or the preparation itself.
General Principles of Compounding