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Risk Management

Ever since introduction of the QBD approach into the CMC review process in 2004, the concept of risk based analysis, development, and management have gained significantly more traction in pharma and biopharma.  In 2006, ICH Q9 outlined how Quality Risk Management can be applied to various elements across the product life cycle.  This document also outlined many tools and analyses which could be used fo this purpose.  While the concept was introduced as a means of improving and simplifying the process, without the right experience, the application of either QBD or risk management can seem overwhelming and complex.

 

Contact us today to find out how we can help you.

What We Can Do For You:

Our hands on experience in risk management and the application of risk analysis tools and techniques can take the complexity out of the picture and help you to take advantage of this powerful approach for:
  • Identification of your product critical quality attributes (CQAs)

  • Establishement of product specifications

  • Prioritization of your development studies and control the scope of your validation

  • Assist you in ongoing investigations (manufacturing, product complaints, etc.)

  • Materials management (supplier assessments, product storage)

  • Laboratory control and stability studies (retest periods and out of specfication investigations)

  • Facility, equipment and utilities (design, qualification, calibration, etc.)

  • Process characterization and process control