Dünya Sağlık Örgütü (DSÖ), Kalite Risk Yönetimi Taslak Kılavuzunu revize etti (İng)
WHO publishes revised Draft Guideline on Quality Risk Management
In August 2010, the WHO published a draft guideline on quality risk management (QRM). With its 24 pages divided into 6 chapters. Now, this draft has been revised and published for comment. The new document is slightly more extensive than the previous draft. The current draft is divided into 7 chapters containing diverse subchapters.
The aim of this guideline is to assist the development and implementation of effective QRM covering activities such as research and development, sourcing of materials, manufacturing, packaging, testing, storage and distribution. In the past, hazard analysis and critical control point (HACCP) methodology, traditionally a food safety management system but subsequently applied to other industries, has been the basis of WHO risk management guidance to the pharmaceutical industry.
In most countries compliance with good manufacturing practices (GMP) (including validation), drug regulatory activities and inspections, together with supply chain controls throughout the product life-cycle, provide good assurance that risks are largely controlled. However, where control is less effective, patients may be put at risk through the production of medicines of inadequate quality. The assessment of individual risks related to specific products and starting materials and the recognition of hazards at specific stages of production or distribution should permit regulatory authorities to improve control of medicines by increasing the effectiveness of their activities within the limits of the available resources. Quality risk management (QRM) is a process that is relevant to all countries and should provide a rationale to understand risk and mitigate it via appropriate and robust controls.
International guidance has emerged that is of specific relevance to the pharmaceutical industry and which addresses the full scope of pharmaceutical industry QRM more effectively than HACCP principles, including how to structure regulatory filings using a risk-based approach. Consequently, this WHO guideline has been developed as an update of WHO advice to the pharmaceutical industry, taking account of this new guidance.
In order to protect patients, in terms of quality, safety and efficacy, international medicines regulatory authorities (MRAs) are recommending pharmaceutical manufacturers to adopt a risk based approach to the life-cycle of a pharmaceutical product. Some MRAs are requiring the adoption of a risk-based approach for certain specific areas in the life-cycle of a pharmaceutical product, e.g. for environmental monitoring for sterile products manufacturing. While the choice of the tools to support the QRM approach is optional and may vary, they need to be appropriate for the intended use.
QRM is the overall and continuing process of appropriately managing risks to product quality throughout its life-cycle in order to optimize its benefit/risk balance. It 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. This guideline will align with the general framework described within other current international guidance on this subject.
The document is largely based on the ICH Q9 guideline and uses its common terminology. Unlike ICH Q9, the draft presents detailed explanations as well as detailed provisions. For example, at least one “Risk Review” should be signed by the quality assurance unit. Verification of the QRM processes and specific QRM applications should be performed by a third party. Chapter 5 (Risk Management Tools) refers to tools which are also described in Annex I of ICH Q9. In addition, a risk matrix in a tabular form describes examples and risk management tools (methods, description of the methods, potential applications) A publication of the “Manufacturing Technology Committee” from the “Pharmaceutical Quality Research Institute” (PQRI-MTC) dated from 2008 is explicitly quoted for the examples presented.