The Challenges and Opportunities in ICH Q10 - Pharmaceutical Technology

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The Challenges and Opportunities in ICH Q10
Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.

Pharmaceutical Technology

Reducing costs and improving efficiency in manufacturing is critical. Efficient processes go hand in hand with processes that are well understood. The focus on efficiency only occurs after processes are already stable, predictable and capable. The issues associated with the availability of a critical product (e.g., flu vaccine) can have an extreme effect on the public. If processes are better understood, and technology transfer could occur more smoothly, then shortage situations would occur less frequently. Products that have efficient manufacturing processes typically are not the products that we fear will run into problems related to market supply. In addition to these effects in manufacturing, reducing costs and speeding up product development can enable important drugs to make it to market faster. The end game of continuous improvement is to improve costs as well as to allow for faster innovation, deeper process understanding, and higher success rates of meeting the needs of the public.

Everybody wants to improve; nobody wants to change. This lies at the heart of all improvements because, after all, improvement is change. The management of this change is extremely important. The systems approach outlined in the quality system must ensure confidence that correct decisions are being made and encourage science and risk based approach to these quality decisions. They also promote process understanding, stressing the link between development and manufacturing, improving quality monitoring and review (based on data methods such as process control and process capability) and encouraging preventive action over corrective action.

The pharmaceutical industry in many ways has been lagging behind many other industries in their adoption of these continuous improvement activities. Having access to these approaches and having regulatory agencies in agreement on the rules of engagement is the important first step.


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