Compounding Pharmacies and the USP <71> Sterility Tests
Scott Sutton, PhD
Owner/Principal Consultant - Microbiology Network, Inc.
Thursday, November 6, 2014
1:00 – 2:00 p.m. CST (2:00 ET / 11:00 PT / 12:00 MT)
IACP Technician or Student Pharmacist Members – $25
IACP Pharmacist Members – $45
Non-members – $70
The compendial Sterility Test has a simple premise - test CSP for the presence of viable microorganisms. However, recent regulatory action has highlighted the difficulties in performing the test compliantly. This one-hour webinar will examine the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The discussion will focus on the compendial Sterility Tests (and their Method Suitability requirements) and provide background needed to understand why a harmonized, if admittedly arbitrary, test is so widely required. The discussion will be summarized with a checklist of considerations to review when considering the outsourcing of this important test.
At the conclusion of this program, the pharmacist and technician attendee will be able to:
- Describe the critical aspects of the compendial Sterility Tests
- Recognize the need for Method Suitability testing in this application
- Describe the need for proactive documentation
- Explain an audit of a Sterility Test facility and report
The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. ACPE UAN 0201-9999-14-114-L04-P, 0201-9999-14-114-L04-T.
If you were unable to attend the live webinar, this program will be converted to the self-paced library 24-48 hours after it is recorded. Please click here to view IACP AdvanCE’s self-paced online webinars that are available today.
All sessions carrying the ACPE program number are approved for continuing education credit. The American College of Apothecaries, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The International Academy of Compounding Pharmacists’ programming is co-sponsored by the American College of Apothecaries.