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SERVICES

Consulting Sterile / Aseptic Products and Sterile Risk Management

SERVICES IN GENERAL

Following activities can be provided:

  • 2 -3 days Workshops about Hot Topics in Sterile Production/ Aseptic Processing/ QA & QC Microbiology
  • Media Fill / Environmental Monitoring / Sterility Testing Expertise
  • Troubleshooting in Microbiological Testing Deviations (Sterility Testing/ Media Fill/ EM)
  • Effective Training and mentoring of Clean Room Operators at the Shop Floor (Videos/ Reports/ ...)
  • Man in Plant Activities
  • Start Up of new Sterile Plants and Utilities (Microbiology QA/QC Activities)
  • Terminal Sterilisation Expertise
  • Risk Assessments for Aseptic Processing 

RISK ANALYSIS

Sterile Product Compliance Risk Analysis 

  • HAZOP or FMEA Risk Assessment of Sterile/ Aseptic Production plants and Microbiology QA/QC systems
  • Results : Total Risk Factor or Risk Priority Numbers, and provide technical solutions and set CAPA´s
  • Target: improve the quality of the sterile / aseptic process to prevent
    • non- sterile product on the market
    • regulatory non- compliance in audits
  • CAPA Effectiveness Verification 

AUDITS

Support in FDA Audit Preparation / Remediation process

  • Preparation for FDA and regulatory agency audits 
  • Support in FDA enforcement action remediations, including Form 483s, Warning Letters 
  • Mock audits 

Support in Due Diligence / Supplier Audits 

Extensive expertise in Microbiological QC labs and Sterile API and FDF Manufacturing, including Solid Product Filling