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Sterile Products and Aseptic Techniques for the Pharmacy Technician CHAPTER Quality Control and Assurance Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved The Seven Rights • • • • • • • Right patient Right medication Right dose Right route of administration Right time Right technique Right documentation Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Quality Assurance Functions • • • • • Written policies & procedures Documentation Personnel training System checks & process validation Daily assessment of all operations Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Quality Improvement • Ensures that integrity is not lost due to – Lack of training – Equipment failure – Outdated facilities – Other noncompliance issues Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Quality Improvement (cont’d) • Process includes – Monitoring trends – Conducting audits – Identifying & analyzing problems – Taking corrective measures – Conducting testing – Suggesting change Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Guidelines FDA • Publishes Good Manufacturing Practices (GMP) • GMP covers compounding sterile products • Other guidelines: manufacture of sterile products • Guidelines include quality system regulations Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Guidelines (cont’d) FDA (cont’d) • Regulations make standards consistent with requirements Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Guidelines (cont’d) The Joint Commission • Publishes standards on – Pharmaceuticals – Facilities that manufacture, store, & deliver them • Constantly revises standards to – Improve compliance – Keep up with drugs & their manufacturing processes Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Guidelines (cont’d) • Performs stringent inspections at timed intervals • Offers accreditation for health care organizations • Offers support to help comply with accreditation Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved Guidelines (cont’d) CDC • Focus: preventing spread of disease/infection • Same focus as goal of aseptic compounding • Provides info for hospital environment controls Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved USP 797: Medium-Risk Level CSPs (cont’d) • Any CSP that is prepared (cont’d) – 30 hrs or less storage @ room temp – days or less refrigerated – 45 days or less frozen Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved USP 797: High-Risk Level CSPs • Any CSP that is prepared (cont’d) – By compounding using nonsterile ingredients – Using sterile contents of commercially manufactured products – Without antimicrobial preservatives – Exposed to less than ISO Class environment for more than1 hr – By improperly gowned personnel Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright ©2011 by Pearson Education, Inc All rights reserved ... (GMP) • GMP covers compounding sterile products • Other guidelines: manufacture of sterile products • Guidelines include quality system regulations Sterile Products and Aseptic Techniques for the... Pharmacy-Prepared Sterile Products • This document – Outlines considerations that are subjected to quality testing & assurance – Addresses all areas impacted by quality assurance Sterile Products and Aseptic. .. standards for sterile compounding – Adopted by state boards, JCAHO, FDA Miscellaneous • Other local, state, & national agencies • Find out what rules apply in your state Sterile Products and Aseptic