31.10.2014 |

LOGFILE No. 28/2014 - Integrated Quality Risk Management

Integrated Quality Risk Management

An excerpt from the GMP MANUAL

by Martin Mayer

Quality risk management (QRM) should ideally be applied proactively during the development, planning and design processes for all elements that have the potential to affect the quality of the product. Early identification facilitates effective control of quality risks and, as a result, risks to the patient.


The sooner risks are identified, the more effectively they can be controlled, reduced and, where possible, eliminated. When QRM is used during the development, planning and design of elements that can potentially affect the quality of the product, the elements can be developed, planned and designed in such a way that the risks can be eliminated in advance with a minimum of effort, resources and cost.


If product quality risks are only identified at an advanced stage of the product life cycle, th required effort and cost of failure increase exponentially and only decrease when commercial manufacture and marketing ceases.

The introduction and integrated application of QRM significantly benefits both industry and responsible authorities.

An integrated and efficient QRM system gives a pharmaceutical manufacturer a cost advantage over competitors who have not implemented an efficient quality risk management.


Industry – QRM facilitates systematic, structured and risk-based development, manufacture and distribution, i.e. risk-based management of a medicinal product's entire life cycle.

Authorities – QRM helps the regulators carry out their monitoring activities (e.g. inspections) in a systematic, structured and risk-based way, facilitating coordination between the various respon-sible authorities and the use of synergy effects.

Scientifically based decision-making

Industry – QRM helps manufacturers make qualified and scientific decisions based on compre-hensive understanding of the process and product. A consequent application of QRM allows greater flexibility when fulfilling GMP requirements and promotes innovation, continual im-provement and increased efficiency. Process control strategies can be focussed on critical process parameters and critical quality attributes; uncertainties can be addressed in a targeted way.

Authorities – QRM fosters informed decision-making with regard to the monitoring or required inspection frequency based on awareness of the product risks (sterile products/non sterile oral solid dosage forms) and the GMP-compliance history of a manufacturer. QRM facilitates a vindi-cable acceptance of residual risk, based on the certainty that a manufacturer makes scientifically and risk-based decisions.

Focusing resources on critical aspects/risk to patients

Industry – QRM facilitates an informed and scientifically based assessment and control of product quality risks and the associated patient risks in order to effectively protect the patient by ensuring the quality, safety, purity and efficacy of the medicinal product. Resources can be used to focus on critical aspects, achieving cost advantages without compromising quality standards as is often the case.

Authorities – QRM allows the regulators allocate their frequently limited inspection resources optimally and concentrate on certain areas, such as on the manufacturers of sterile products or on manufacturers with a problematic inspection history.

Prevention of restrictive and unnecessary practices

Industry – Integrated QRM helps prevent the use of restrictive practices that are frequently associated with the formality of quality management systems by decision makers. QRM uses efficient and lean processes to prevent systems being overloaded and minimise business risks: e.g. risks caused by rejection of an application for the approval of a new medicinal product, or by the suspension or withdrawal of a manufacturing license due to unsatisfactory inspection results. QRM supports the introduction of technological innovations that were frequently blocked in the past by restrictive official interpretation of the qualification and validation requirements for equipment, systems and processes ("never change a validated system").

Authorities – QRM helps the authorities adjust the degree of monitoring necessary for the indi-vidual manufacturers. Manufacturers with a good inspection history benefit because they are required to undergo fewer inspections which generally take up a significant amount of resources. QRM helps the authorities support the industry when introducing improvement and innovation.

Promotion of transparency and communication

Industry – QRM promotes modern matrix organisations and enables the sharing of responsibility between the organisations and sub-organisations of a company within the overall system. QRM promotes the generation of knowledge and its subsequent transfer to all of the decision makers and stakeholders. QRM uses the transparency created by generating knowledge and sharing information to help establish a culture of mutual trust in the company or organisation, fostering the team spirit among the decision makers and stakeholders.

Authorities – QRM supports open communication between the authorities and the industry, allowing a conscious and informed dialogue with the aim of guaranteeing a supply of safe and high quality medicinal products to the patients, stakeholders and interest groups.

QRM is a systematic process for assessing, controlling, communicating and evaluating risks to the quality of the medicinal product. QRM should be used both preventively and retroactively in all areas of a pharmaceutical quality management system. QRM is a holistic and continuous approach to guaranteeing an appropriate management and control of product quality risks during the entire product life cycle of a medicinal product, and to determining the risk, effort and benefit ratio optimally.

The article is an excerpt of the new Chapter 10 Quality Risk Management of our GMP MANUAL.


Martin Mayer
Fresenius Kabi Deutschland GmbH, Germany

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