Achieving Global Consensus through the International Conference on Harmonization - The science embedded in the ICH Quality documents can help transcend regional differences and lead to scientific harm

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Achieving Global Consensus through the International Conference on Harmonization
The science embedded in the ICH Quality documents can help transcend regional differences and lead to scientific harmonization.


BioPharm International


The concepts embedded in Q8 transcend its application solely to drug products. Most of the comments to the docket for the version posted as FDA guidance suggested expanding the applicability towards drug substances and larger molecules. ICH Q8 is now being revised to clarify its revolutionary concepts. Discussions are under way within ICH about extending the concepts to active pharmaceutical ingredient (API) development, including both new chemical entities and biotechnology drug substances.

ICH Q9: Quality Risk Management

Q9 is the repository for the risk-management tools to be applied both in Q8 and Q10. John Berridge, who is vice president for Pfizer Global Research and Development and the rapporteur for the initial stages of Q8 and now its revision, described Q9 as a collection of tools, drawing the comparison between wrenches, pliers and hammers, which can be used, per the guidance, to put a car together (development) or to maintain a car (commercial manufacturing). Risk Management tools are commonly used in many other industries, most notably the insurance industry, to analyze, evaluate, and manage risks. The guidance describes examples of how to apply the tools to a variety of pharmaceutical systems.

When first faced with implementing Quality Risk Management, one could become paralyzed with indecision about which tool to use in a given application. Unlike statistical analysis, where it is necessary to understand the data (normality, randomness), in quality risk management there is no wrong tool to use, since there are no statistical rules to violate. The correct tool is the one the user feels most comfortable with. In the total absence of experience, one can look at other applications of Quality Risk Management. For example, a recent FDA white paper, which discusses applying risk management to determining inspectional priorities, is an excellent example of risk ranking and filtering.4 Quite often, failure mode effect analysis (FMEA) works well in conjunction with a six-sigma approach.

One must be cautious, however, about applying risk management to justify an incorrect decision. For example, Quality Risk Management does not mean risk can be accepted and used to justify the release of a batch that should be rejected. Bad risk analyses should not be used as a basis for poor decisions.

Rather, Quality Risk Management can be used to facilitate consistent decisions. The risk-management process encourages a multi-disciplinarian approach to bringing different experiences to bear on risk analysis. Quality professionals bring unique experiences to their daily work. By creating a process where collective experiences can be used in a structured approach, the resulting decisions will be stronger than decisions based on limited experience or knowledge would be.

Since Quality Risk Management is flexible, there will be many applications for its use. As a scientific process, it can be used in many quality systems both in development and commercial manufacturing. However, there is no reason to create a separate Quality Risk Management Department; this would probably discourage the wide usage of Quality Risk Management envisioned by the authors of the guidance document. Instead, Quality Risk Management should be a tool used by many diverse disciplines and departments.

Each firm will need to define the documentation requirements for informal and formal risk management processes. These requirements will depend on the depth of the risk management process, and its criticality and role in supporting current good manufacturing practices (GMP) activities. Proper GMP record keeping and documentation will still be a cornerstone in the application of Quality Risk Management.

ICH Q10: Pharmaceutical Quality Systems

Q10, Pharmaceutical Quality Systems, is currently at step 1 in the ICH process—the initial Expert Working Group is developing and drafting the document.

Within Q10, three elements have been discussed5 :

  • Quality management
  • Product realization
  • Continual improvement

Quality management synthesizes all of the quality indicators that help to uncover systemic issues, determine priorities, and drive improvements. To comply with GMPs, a given site develops a set of standard operating procedures that define how the site will operate. These procedures detail requirements for such quality systems, such as deviations, complaint handling, training, internal auditing, validation, and change management. These concepts are irrespective of technology or national requirements but capture that intangible asset known as the "quality culture." Quality management synthesizes all of the quality systems to develop a comprehensive approach to address quality issues, make improvement, and create the quality culture.


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