ICQ Consultants is Re-Branding

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We are very excited to announce the launch of our newly designed website.  The new interactive website has a bold, clean look as does our new ICQ logo.

Our more user-friendly website interface and homepage layout providescompass current and prospective clients with useful information about our services and our company.  For our prospective future employees, our new website provides an easy to navigate application site where they can directly apply to our open positions.

ICQ Website:

ICQ’s new website offers maneuverability throughout our different tabs offering content such as:

  • A direct means for our  clients to contact us
  • Case studies and client testimonials
  • Latest news, events and blogs
  • ICQ Careers
  • An introduction ICQ’s management team

We would love to hear from you…

Please take a moment and check out our new website.  We would love to hear your feedback, please send any thoughts or comments to icq@icqconsultants.com.

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Principles of Quality-by-Design in Pharmaceutical Development

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The Key Concept:

The Quality-by-Design (QbD) concept is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management [ICH Q8 (R2)]. A key assertion of QbD is that quality is controlled not by simply testing the product, but rather that quality is built into the manufacturing process by design. This is achieved by a control strategy that is based on both product and process understanding.

Practical Implementation:

Stage 1 (Process Design) of the Process Validation Lifecycle is where Quality-by-Design implementation is facilitated:

1

Within this workflow there are multiple risk assessments and deliverables that should be met to develop a robust process and analytical control strategy. They are:

2

These deliverables and risk assessments form the basis of design of the product, establish critical quality attributes (CQAs) and process performance indicators (PPIs) of the process, identify process parameters, material attributes and raw materials with potential impact on CQA and PPIs, and ultimately classify process parameters, material attributes and raw materials as critical or non-critical. All together, these items coalesce to create a comprehensive control strategy for the life-cycle of a product. A comprehensive control strategy is derived from current product and process understanding, that assures process performance, and that a product of required quality will be produced consistently.

Final Thoughts:

A systematic approach like QbD can potentially facilitate continual improvement and innovation throughout the product life-cycle.

 

Written By: Gregory Fischer, Consultant II

ICQ Consultants, Corp.