ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
- The quality objective of manufacturers is to ensure that products are fit for their intended use, comply with the requirements of the Marketing Authorisation (MA) and do not place patients at risk due to inadequate safety, quality, or efficacy.
- The fulfillment of quality objectives is the duty of senior management and requires the involvement and commitment of all staff in all departments and at each level within the organization and also by the
company’s suppliers and by the distributors. - For fulfillment of quality, objectives must be a comprehensively designed and correctly implemented system of
Quality Assurance (QA) incorporates Good Manufacturing Practice (GMP), Quality Control (QC), and Quality Risk Management (QRM). all the activity related to quality needs to be fully documented and its effectiveness monitored.
Quality risk management
is a systematic process for the assessment, control, communication, and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
The quality risk management system should ensure that:
- The evaluation of the quality risk is based on scientific knowledge, and experience with the process.
- The level of effort, formality, and documentation of the quality risk management process is commensurate with the level of risk.
The primary objective for implementing ICH Q9 was to improve the implementation of risk-based approaches / the principles of quality risk management within the pharmaceutical industry and regulatory environment.
QRM aspects should be an integrated part of the planning and content of all GMP inspections including for final products as well as for active pharmaceutical ingredients
The objective is to ensure the extent to which a company can demonstrate that it has a systematic approach to the integration of the principles of QRM into its operational systems, and its involvement and active support by senior management.
QRM is not a separate system of QA, it should be fully included and implemented in QMSystem.
The QRM process consists of the following steps:
– Process mapping identifies all inputs, outputs, and existing control measures.
– Risk Assessment – risk- identification, risk analysis, and evaluation
– Risk Control – risk reduction and risk Acceptance
– Communication (i.e. the residual risk should be communicated to the regulators and customers;
– Regular Review of the risks.
The following evidence needs to collect that:
– The use of QRM is planned
– The key elements of the QRM program are clearly defined and documented
– Senior Management provides visible support to QRM.
– Key outcomes of QRM are communicated to and acted upon by Senior Management.