ICH-Q10: A Recipe for the Product Life Cycle - Pharmaceutical Technology

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ICH-Q10: A Recipe for the Product Life Cycle
The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.


Pharmaceutical Technology



Figure 2: The interrelationship of the quality system to all other systems involved in manufacturing.
The FDA guidance on quality systems is is intended to serve as a bridge between the 1978 regulations and the agency's current understanding of quality systems (4, 5). FDA recognized that modern quality systems, when coupled with manufacturing process and product knowledge and the use of effective risk-management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions. Manufacturers with a robust quality system and appropriate process knowledge can implement many types of improvements. Moreover, lowering the risk of manufacturing problems through an effective quality system, may result in shorter and fewer FDA inspections (5). Figure 2 shows the interrelationship of the quality system to all other systems involved in manufacturing.

Many of the concepts embodied in the FDA's quality-system guidance are reflected in ICH Q10. "ICH Q10 represents the pharmaceutical quality system that compares very well with the quality-system guidance in terms of quality management, continual improvement, the use of data to be converted to knowledge for continual improvement, and the idea of ownership for quality and manufacturing being primarily the firm's responsibility," says FDA's Famulare.

The potential of ICH Q10

Demonstrating effective pharmaceutical quality systems and product and process understanding, including the use of quality risk-management principles (e.g., ICH Q8, ICH Q9, and ICH 10), offers important opportunities for the pharmaceutical industry to:
  • Increase use of risk-based approaches for regulatory inspections
  • Facilitate science-based pharmaceutical quality assessment
  • Optimize science- and risk-based postapproval change processes to maximize benefits from innovation and continual improvement
  • Enable innovative approaches to process validation
  • Establish real-time release mechanisms (4).

What's next for ICH Q10


International effort: The Pharmaceutical Inspection Convention and Pharmaceutical Co-operation Scheme
ICH has issued the draft ICH Q10 for public comment in the United States and European Union and is scheduled to do so shortly in Japan. Those comments will be delivered to the ICH meeting in spring 2008 in Brussels to consider for incorporation into the Step 2 draft. Step 2 of the ICH process is reached when the ICH Steering Committee agrees, based on the report of the Expert Working Committee, that there is sufficient scientific consensus on the technical issues for the draft guideline or recommendation to proceed to the next stage of regulatory consultation or Step 3. The next step is Step 4 or adoption of the ICH guideline. Step 4 is reached when the ICH Steering Committee agrees, on the basis of the report from the regulatory Rapporteur of the Expert Working Group, that there is sufficient scientific consensus on the technical issues. Step 4 is followed by Step 5 or implementation.

"Depending on the number and extent of the comments we will see if we can achieve adoption in spring 2008," says Famulare. ICH's Expert Working Group will met in Yokohoma, Japan, in fall 2007 as feedback from the current public comment period is assembled.


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