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New “Points to Consider” on Product Development, Risk Management and Quality Systems

If you still have concerns on how to implement the three key ICH Guidelines Q8, QA9 and Q10 into your company’s product development and manufacturing plans and quality management system, you can rest easy – help is at hand from ICH. The Quality Implementation Working Group (IWG) issued a “Points to Consider” Guide (PTC) for these three guidelines, which was published on the ICH web site in July. The document has considerable credibility, as it is based upon questions raised during 2010 training workshops held in the US, EU and Japan. It is intended to supplement ICH’s December 2010 Question & Answer document and the training materials that ICH has made available on its web site.

The most useful “Points to Consider” are those discussing the relationships between risk and criticality and between criticality and control strategy. The level of risk is determined by an assessment of severity, occurrence and detectability, and it can be altered by the application of risk management techniques. But the criticality of a quality attribute is primarily based upon the severity of the risk and is not changed by risk management activities. Since the criticality of a process parameter is linked to the probability of occurrence and detection, risk management may reduce the risks associated with this attribute. In other words, companies can use risk management to define the critical quality attributes, but they would use risk management to control the level of risk and determine the acceptable limits of the resulting critical process parameters.

This concept is crucial in the application of Q8 and Q9 and this highly relevant document can significantly increase understanding of the principals involved. Furthermore, the PTC guide discusses the concept of the Control Strategy Life Cycle. The document explains that control strategy is an essential tool in ensuring that CQAs are met in all stages of product development. Therefore, it has a life cycle that runs parallel to that of the product. As knowledge of the product and the manufacturing processes improves, the strategy will involve making changes to acceptance criteria, analytical methods and/or sampling points. Control strategy development should take into consideration the effects of scale-up and transfer of manufacturing to another facility, presenting yet another opportunity for the use of Quality Risk Management tools.

The Control Strategy discussion is taken even further in the introduction of Real-Time Release Testing. This technique may take some time to be implemented in the biopharmaceutical industry, but it needs to be considered now, in order to plan for the day when suitable analytical and control tools become available.

In all, this “Points to Consider” guide is required reading for anyone currently involved, or planning to be involved, in the implementation of the three key Guidelines in successful product development. But, remember, however you are applying the concepts of Q8 – 10 and QbD, compliance with the current GMP regulations is still required.


Blog article by: Alex Kanarek