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Clinical IQ's Quality Standards for Large Scale Compounding

Clinical IQ, LLC has authored and released a paper, titled Quality Standards for Large Scale Sterile Compounding commissioned by the Pew Charitable Trusts. The paper chronicles the changes in scope and magnitude of sterile drug compounding from the 1980s to the present day and contrasts the quality systems established for pharmaceutical companies that manufacture drugs with those established to guide traditional pharmacy sterile compounding practice. It is hoped the paper will establish a common understanding and stimulate a dialogue regarding the more robust safeguards that are needed when compounding occurs on larger scales whether through registered 503B outsourcing facilities or the traditional 503A patient-specific pharmacy operations.

To read this paper click here or to view the cGMP-797 Crosswalk resource click here

 
2014 USP 797 Compliance Study is now open

The 2014 USP 797 Compliance Study is now open and I encourage you to participate.

The 2014 USP 797 Compliance Study is now open and will run through June 30, 2014. Originally performed in 2011 and again in 2012 and 2013, the study is the largest and most comprehensive investigation of compliance ever undertaken. The ongoing USP 797 Compliance Study is led by sterile compounding experts Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. We believe that the information gathered and the insights gained from the data will be valuable to the industry, will inform compounding decision-making and will facilitate ongoing improvements to patient safety.

The 2014 USP Compliance Study uses a sophisticated web-based Gap Analysis Tool which Kate and I developed and have been using in our assessments of sterile compounding practice at industry locations for several years. This tool was made available at no charge to all study participants. It should also be noted that ALL INDIVIDUAL FACILITY RESULTS ARE CONFIDENTIAL - ONLY AGGREGATE DATA IS USED IN THE STUDY REPORT.

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New Policies and Procedures Templates Available for Purchase

With USP Chapter <797> becoming official on June 1, 2008, a big part of your management responsibility will be creating, updating, and, most importantly, enforcing policies and procedures.   That is why ClinicalIQ is now making available 20+ years of clinical, operational and management experience in the compounding industry by offering you the opportunity to purchase a set completely updated Policies and Procedures templates.   These templates will help you comply with the new regulations as our policies and procedures have already been updated to reflect the revisions. Why spend your time – which is money – reinventing the wheel – let ClinicalIQ's experience help you.

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