Center for Pharmaceutical Cleaning Innovation
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Visual Inspection Programs

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The EMA and PIC/S have recently allowed the use of visual inspection to replace analytical testing (swab) at product changeover, BUT only if visual inspection can be demonstrated to be reliable.
CPCI™ developed an ASTM Standard Practice Guide with the participation of FDA, MHRA and WHO that provides detailed guidance on qualifying inspectors for visual inspection
(ASTM E3263).

    Need help setting up a compliant Visual Inspection Program??

    CPCI™ has developed a simple, cost effective and statistically-based procedure for qualifying all operators and inspectors to perform a Visual Inspection in compliance with regulatory expectations and the ASTM E3263 Standard Practice Guide.

    Contact 
    CPCI™ today!

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CPCI™ is the pioneer in the development of statistically-based qualification of Visual Inspection.  Our research can help you implement a Visual Inspection program that qualifies all of your operators, is scientifically and statistically defensible, and can speed up the release of equipment for return to manufacturing for significant time and cost savings.

CPCI™ has also developed an APP that can simplify data collection and analysis and avoid transcription errors associated with paper-based forms and help assure Data Integrity.

CPCI™ can also provide a "double-blind" qualification study of operators/inspectors as described in ASTM E3263. Contact CPCI™ for more information.

We have also developed patent pending software for bringing visual inspection to the next level.

The Center for Pharmaceutical Cleaning Innovation is a Non-Profit Research Organization providing research and educational opportunities in Cleaning Process Development and Validation
Content Copyright 2022. All rights reserved.
[email protected]
(908) 507-7743

  • Home
    • About
    • Board of Directors
    • Testimonials
  • Research Services
    • Cleaning Process Development
    • TOC Method Development
    • Visual Inspection
    • Statistical Analysis
  • Education
    • Certified SME in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation
    • Certified Lean Six Sigma Green Belt
    • Publications
    • Training, Seminars, Webinars, Internships
  • Store
    • Cleaning Validation Coupons
    • Cleaning Validation Coupon Information >
      • Materials of Construction
    • Coupon Cleaner
    • CPCI Textbook
  • Donations
  • Contact
  • CPCI™ Software Page
    • HBEL Calculator Page