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.
Approved by the pharmacist in charge.
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.
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.
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.