Implementing United States Pharmacopeia Chapter <1163>. Quality assurance in pharmaceutical compounding, Part 3: Testing.
A good quality-assurance program is guided by written procedures that define responsibilities and practices that ensure compounded preparations are produced with quality attributes that are appropriate to meet the needs of patients and healthcare professionals. It also contains a testing or preparation evaluation component to provide feedback on the accuracy and repeatability of the procedures used in the pharmacy. As a final check, the compounder shall review each procedure in the compounding process to verify it has been followed correctly. To ensure accuracy and completeness, the compounder shall observe the finished preparation to ensure that it appears as expected and shall investigate any discrepancies and take appropriate corrective action before the prescription is dispensed to the patient. In addition, testing may be required or recommended depending upon the situation.
International Journal of Pharmaceutical Compounding, Inc., Edmond, Oklahoma 73034, USA. lallen@ijpc.com
Loyd V
LV
Allen
D004339:Drug Compounding / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000032:analysis; D010602:Pharmacopoeias as Topic / Q000592:standards*; D013242:Sterilization; D014481:United States
D004364:Pharmaceutical Preparations