Quality Risk Management guidance

However the latest thinking provided by the United States Food and Drug Administration (FDA) in the Guidance for Industry for Quality Risk Management suggests that all qualification activities for analytical instruments should be performed using a risk-based approach. 

Guidance for Industry Q9 Quality Risk Management, United States Food and Drug Administration, June 2006. 

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2006, June), Guidance for industry Q9 Quality risk management, DHHS, Rockville, MD. 

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). 

International Conference on Harmonization. 2006. Q9 Quality risk management, http // www.fda.gov/cder/guidance/index.htm. Accessed June 8, 2007. 

While the foundation of QbD was laid in the FDA guidance documents, the paradigm shift continued to evolve through the release of three ICH documents (described later) ICH Q8(R1), Pharmaceutical Development, ICH Q9, Quality Risk Management, and ICH QIO, Pharmaceutical Quality Systems. ... 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

The end product of much risk management work is a report. It is vital to recognize that the timeliness and quality of the report itself are as important as the work that went into its creation. All too often a report is delivered late. The report itself may be incomplete, cryptic, either too long or too short, and hard to follow. Guidance to do with clear writing is provided in Chapter 6. Additional thoughts are provided here. 

The issue that must be managed is the appropriate threshold to communicate the change and initiate appropriate approval processes. Tolls subject to regulatory requirements may use the regulatory guidance as the threshold for management of change processes other tolls must establish the threshold appropriate to process risks, quality systems, and business concerns. 

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