Quality risk management

Quality Ten topic headings—Stability, Analytical Validation, Impurities, Pharmacopoeias, Quality of Biotechnological Products, Specifications, GMP, Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality System total of 24 guidelines... 

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. 

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. 

Harmonised Tripartite Guideline Quality Risk Management Q9 (step 5). In The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 2005. 

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

Also at this meeting which included, as well as he above, WHO, EFTA and the self-medication industries, work continued on the text of a guideline on Quality Risk Management for the pharmaceutical industry (Draft 4 was produced and will be finalised in April 2005) Other topics discussed included Pharmacopoeial Convergence/ )... 

Cough P. and Roenninger S. New Guideline on Quality Risk Management for fhe Pharmaceutical Industry takes shape. The Regulatory Affairs Journal-Pharma 2005 16 91-93. 

Robustness of a company s quality risk management activities... 

The FDA has endorsed quality risk management as part of an overall quality systems approach to compliance with the cGMP regulations and achieving overall... 

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. 

A consensus vision statement was drafted at the July 2003 ICH meeting with regard to the objective of the ICH in harmonizing the efforts of regulatory bodies to establish quahty systems approaches in their operations Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science. ... 

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). 

FIGURE 11 Schematic of quality risk management process described within ICH Q9. 

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

Internal Conference on Harmonization (ICH) Q 9—Quality Risk Management. 

International Conference on Organization (ICH) (2005), Draft consensus guideline quality risk management Q9, draft. 

Quality risk management (QRM) is illustrated by practical examples about logistics, equipment, pharmaceutical care on the wards and clinical pharmacy. 

Pharmacists will, in their work, reflect on all processes for which they are responsible, with the purpose of improving quality and availability of medicines and hence to minimise any risk of harm to patients. Quality risk management (QRM) offers a structure and tools for a systematic approach to these efforts. The process usually consists of the phases risk assessment (Sect. 21.3.1) (with sub processes risk identification, risk analysis and risk evaluation) and risk control... 

ICH Guideline Q9 is the reference document on quality risk management for pharmaceutical preparations [1]. Therefore in this chapter mostly ICH Q9 definitions are used. Many of them are identical to those of the International Standards Organisation (ISO, see also Sect. 35.7.2). 

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