A Fresh, Affordable Pathway to Compliance and Quality For the Compounding Pharmacy Industry
The ONLY Risk-Based Auditing and Accreditation Model in Compounding
Experienced Auditors > Commitment to Excellence > Far Lower Cost
Our Method and Approach
Prepare clients for whomever might walk in the door:
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USP
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DEA
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FDA
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HIPAA
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OBRA 90
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State boards of pharmacy
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Nonresident licensure inspections
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GDP – Good Documentation Practices
Risk-Based Versus Checklist-Approach to Auditing:
How does CCE define “risk”?
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Based on FDA’s ICH Q9(R1) definition:
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Risk = Severity X Probability X Detectability
Scope of risk:
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Patient harm
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Worker harm
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Financial harm
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Litigation
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Regulatory
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Operational efficiency
Collaborative Process:
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Premium placed on providing suggestions and information, not just findings.
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Deficiency encountered? Auditor immediately clicks into “solution mode” with the client.
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Many pharmacies might be surprised at the number of initial “findings."
We Focus on Quality:
No other 503A accreditor invests the number of auditor hours that CCE does:
Ongoing assessment and support:
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CCE requires the submission of a small number of documents to maintain accreditation.
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If this is seen as onerous, the client has far bigger problems!
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Ongoing mini-self-audits.
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Ongoing presentations on key topics.
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While CCE refers clients desiring true consultative services to a small list of other entities, we’re always there to offer answers and advice.
A return to auditors with deep experience and expertise.
A two-phase process:
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Preliminary office review of most documents
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On-site audit focused on observation, follow-up, interactions
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Multiple eyes on your processes and paperwork
Summary:
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Broad scope
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Risk-based versus checklist-approach to auditing
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Collaborative approach
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Unprecedented auditor investment
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On-going monitoring and support
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Low overhead equals low cost