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Q: What is Q9?
A: It refers to a document titled “Guidance for Industry: Q9 Quality Risk Management,” issued by the
FDA in June 2006.
Q: What is it about?
A: The guidance, which is for industry and regulators alike, offers a systematic approach to quality
risk management. It outlines principles and examples of tools for quality risk management that can be
applied to all aspects of pharmaceutical quality. These aspects include development, manufacturing,
distribution, inspection, and submission/review processes throughout the lifecycle of drug substances,
drug products, biological, and biotechnological products. The guidance aims to help industry and
regulators make more effective and consistent risk-based decisions.
A: Unlike other FDA guidances, Q9 was prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
This group provides a forum for harmonization initiatives based on input from regulatory, industry,
and consumer representatives. Its goal is to achieve harmonization of technical requirements for the
registration of pharmaceutical products in the United States, the European Union, and Japan.
A: Risk is defined in this guidance as the combination of the probability of occurrence of harm and
the severity of that harm. Pharmaceutical manufacturing entails a degree of risk. Q9 focuses on the
importance of managing product quality risks. The guidance says: “It is important to understand that
product quality should be maintained throughout the product lifecycle such that the attributes that are
important to the quality of the drug product remain consistent with those used in the clinical studies.”
Under Q9, quality risk management is a systematic process for the assessment, control, communication,
and review of risks to the quality of the drug product across the product lifecycle.
A: Both industry and regulatory personnel (reviewers and inspectors) can implement Q9 by assessing
and managing risk using recognized risk management tools and/or internal procedures. The guidance
suggests some risk management tools.
A: The main body of the Q9 guidance explains what risk management is and the advantages of applying
appropriate risk management tools. Annex II of the guidance identifies potential uses of quality risk
management principles depending on a company’s situation. One of the areas suggested is integrated
quality management system. By incorporating risk management in the quality management system,
companies can make informed, practical decisions about the use of existing resources.
The MasterControl software solution provides a solid quality management infrastructure that will make
continual quality improvement possible. Using MasterControl as a platform for quality management
and FDA compliance makes risk management more feasible because quality processes become more
transparent and easier to monitor. With MasterControl, performing risk assessment, risk control, risk
communication, and risk review is more manageable.
The following are some of the areas of quality management where risk management could potentially be
incorporated and how MasterControl can help.
Q9, Annex II: Potential Applications for Quality The MasterControl Solution
Risk Management
Documentation (Determine the desirability of and/or MasterControl Documents™, the building block
develop the content for SOPs, guidances, etc.) within the MasterControl quality suite, automates and
streamlines document routing, approval, escalation,
and revision control. Provides a single, Web-based
repository for all quality documentation, making risk
assessment of SOPs, policies, and other documents
easier. Provides advanced analytics and reporting
capability for a real-time view of the system.
Auditing/Inspection (Define the frequency and scope The MasterControl™ suite facilitates FDA
of audits, both internal and external, based on certain compliance by optimizing processes and keeping the
factors.) quality system always ready for internal audits and
FDA inspections. All relevant documents and records
will be stored in a centralized, Web-based repository,
making it easy to track and retrieve them during audit
or inspection.
Periodic Review (Select, evaluate, and interpret trend MasterControl Analytics™, a reporting solution
results of data.) available across MasterControl applications, provides
real-time reports that will show trends by process, by
product, etc. It includes dashboard, drill-down, and
advanced scheduling features.
For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com,
or call, 800-825-9117.
MasterControl’s integrated quality management system helps connect quality processes enterprise-wide. The solution
provides automatic triggers to ensure tasks for handling quality-related incidents don’t fall through the cracks.
MasterControl’s integrated architecture ensures that the completion of one system process automatically launches the next
quality sub-system until the process loop is closed. Managers have analytical and reporting capabilities at their fingertips
to track and manage each quality process through completion.
P. 800.825.9117
F. 801.942.7088
www.mastercontrol.com