1  FDA Guideline on Sterile Drug Products Produced by Aseptic Processing,June 1987,pp.20-27;PDA Technical Monograph No.2,Validation of Aseptic Filling for Solution Drug Products,1980.

2  Approved by the pharmacist in charge.

3  note— 70%isopropyl alcohol (IPA)may harbor resistant microbial spores.Therefore,IPAused in aseptic areas should always be filtered through a 0.2-µm hydrophobic filter to render it sterile.

4  Other accepted terms that describe activities aimed at assessing and improving the quality of care rendered include Continuous Quality Improvement,Quality Assessment and Improvement,and Total Quality Management.

5  The use of additional resources,such as the Accreditation Manual for Home Care from the Joint Commission on Accreditation of Healthcare Organizations,may prove helpful in the development of a QAplan.