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, IPA used 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 QA plan.