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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.