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.
Figure 2: 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
- 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
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.
International effort: The Pharmaceutical Inspection Convention and Pharmaceutical Co-operation Scheme
"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