Quality risk management process

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

Risk review should be conducted to evaluate the outputs of the risk management process and repeated as necessary, based on new quality data or if there are process or product changes. 

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... 

The standard operating procedure for extemporaneous preparation of capsules should reflect the decisions on quality risk management of that process. The level of quality risk management should be accounted for in the quality manual of the pharmacy. 

Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. For some types of harms, even the best risk control might not entirely eliminate risk. In these circumstances it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level. This (specified) acceptable level will depend on many parameters and should be decided on a case-by-case basis. For in every case specific measures are created for diminishing the risks, for instance in-process controls may contribute significantly to decrease the risks of extemporaneous preparation, see Sect. 34.6. Examples of parameters... 

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. 

Subsequently, system control was introduced, through defining preconditions for the prime processes, such as well-trained personnel, adequate premises and equipment. Continuous improvement was going to be supported by, among others. Root Case Analyses and Systems for Corrective and Preventive Actions (CAPA). The need was recognised of structured decisions based on (Quality Risk Management (see Chap. 21). 

The guidelines on the Pharmaceutical Quality System may be used as a structure for a PQS, however GMP Chap. 1 already points at ICH QIO as being more suitable for that purpose. ICH QIO provides structure for the design processes and for skills such as knowledge and quality risk management, review of trends and patient satisfaction. These skills enable effective quality management. 

Recall Quality Review Quality Improvement Risk Management Process Optimisat ion Personnel Qualified Person Development... 

It may be seen that the system safety approach is very closely allied to the risk management approach. Indeed, the logical progression of system safety management techniques has been incorporated into many risk management processes, and also to other linked disciplines such as total quality management and environmental management systems. 

The risk management process must be documented, like a quality management system, and the manufacturer must establish acceptable risks for a device, based upon regulations, standards, state-of-the-art and other relevant factors. 

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