CQV #5: Problems in Aseptic Technique Qualification

Coordinated by Paul L. Pluta

CQV – Compliance in Quality and Validation – presents real-life stories reflecting compliance problems in the pharmaceutical, medical device, and related industries.  Previous discussions have included:

CQV #1:  Overview and Invitation to Participate, published in Journal of GXP Compliance (JGXP), Volume 22, #5, and in Journal of Validation Technology (JVT), Volume 24, #5

CQV #2:  Like-for-Like Problems.  JVT, V24, #3

CQV #3:  More Life-for-Like Problems.  JVT, V24, #5

CQV #4:  Animal Tales.  JGXP, V22, #6.

Readers are invited to contribute content, suggestions, comments, and ideas to improve this feature.  All published content will be anonymous – there will be no connection to companies or organizations.  CQV will be most useful when the quality and validation communities submit experiences that will help colleagues improve actual work situations.  Please contact coordinators Paul Pluta at paul.pluta@comcast.net or Melissa Carella at melissa.carella@cbinet.com with content, comments, suggestions, or topics for discussion.


This discussion addresses problems experienced with qualification or competency testing of manual aseptic technique performance.  This testing verifies acceptable aseptic skills by technicians in their functional job responsibilities.  The term “qualification” in this discussion is defined to confirm acceptable technical performance; pharmacy sterile compounding practices as regulated by USP <797> requires verification of technician “competency.”  Thus, qualification and competency are synonymous terms in describing aseptic technique testing.

Job activities addressed by this testing encompass IV medication preparation in hospitals, microbial identification testing in pharmaceutical industry microbiology laboratories, manufacturing processes in FDA 503b compounding pharmacies, aseptic research activities in clinical settings or university labs, aseptic processes in medical device manufacturing, and similar activities.  Successful test performance confirms the acceptable techniques performed by technicians and approves them for future aseptic work.  Testing is then periodically repeated to demonstrate ongoing personnel competence based on the procedural risk level.

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