Q9, quality risk management

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

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

ICH Q8(R1) Pharmaceutical Development, Nov. 2008 ICH Q9 Quality Risk Management, Nov. 2005 ICH QIO Pharmaceutical Quality System, June 2008. 

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 (ICH) (2005), Q9 Quality risk management, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

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

International Conference on Harmonization (ICH) (June 2006) Guideline Q9, quality risk management. 

EU GMP defines QRM as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. All efforts in QRM are aimed at minimising any risk for the patients due to inappropriate quality of the products . QRM is elaborated in EU GMP in Part III as ICH Q9 Quality Risk Management. 

ICH Q9 Quality Risk Management provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality, most of them directed to complex manufacturing situations. It is included in Part 111 of current GMP (see Sect. 35.5.7). It is further dealt with in Chap. 21 Quality Risk Management. 

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. ... 

Q9 Quality Risk Management, Current Step 4 version International Conference on Harmonization, issued on November 2005. 

Analytical scientists and their data help to ensure a sound documentation of the risks and quality of a product. ICH Q9 (Quality Risk Management) offers a systematic approach to quality risk management and complements other existing quality practices that are to be maintained throughout the product life cycle. 

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