USA: Industry Guidance On Quality Risk Management Q9 (R1)

FDA recently (in May 2023) released the revised guidance titled “Q9 (R1) Quality Risk Management” specifically focused on the quality risk management principles and tools which can be applied to the pharmaceutical sector. The final guidance is the targeted revision of the 2006 guidance for the industry.

The term risk is generally defined as the combination of the probability of any harm occurring and the severity level of that harm. In order to enhance a better-quality risk management system, the pharmaceutical industry is implementing the principle and framework of ICH Q9 and ICH training materials as main instruments. Quality risk management in the pharmaceutical industry is proven to be vital in building effective quality systems.

There are 2 key principles in quality risk management:

1. The evaluation of the risk to quality based on scientific knowledge

2. The level of effort, formality and documentation of the quality risk management should parallel the risk level

- Process of Quality Risk Management

Figure 1: Process of quality risk management

The figure above is the general framework example of the quality risk management that can be applied for assessment, control, communication and risk review to the quality of the medicinal products. The process is divided into 3 categories: risk assessment, risk control and risk review. The activities will be carried out by a team consisting of experts from various areas for instance, regulatory affairs, product operations and sales and marketing.

- Quality Risk Management Methods

A scientific approach is one of the important elements in quality risk management. Transparency and accurate methods aid the risk management process to trace the possible harms, the severity level and the detectability of the harm risks. Other than basic risk management methods, risk ranking and filtering and supporting statistical tools, listed below are lists of possible tools that can be applied in quality risk management by industry or regulators. It is important to note that, neither all tools nor only one tool is acceptable for any scenario. The tools are applicable in variant scenarios.

- Failure Mode Effects Analysis (FMEA)

FMEA applies to evaluate possible failure modes for processes and/or product performances. This method will break down the process analysis into manageable steps and is suitable to use for summarizing failure modes, causing factors and effects. FMEA can be applied to equipment, facilities and use in analyzing manufacturing operations.

- Failure Mode, Effects and Criticality Analysis (FMECA)

FMECA may assist in identifying additional actions to minimize risks by investigating probabilities of occurrence or severity level of the effects. FMECA can be applied to manufacturing processes.

- Fault Tree Analysis (FTA)

FTA can asses the system failures one at a time but combined multiple failure factors by identifying casual chains. FTA relies on experts’ understanding of the process in order to detect the failure factors. FTA can be applied for risk assessment and building up monitoring programs.

- Hazard Analysis and Critical Control Points (HACCP)

HACCP consists of 7 steps in analysis, evaluation, prevention and controlling the harm risk due to the design, development, production and product usage. HACCP is helpful in securing product quality, reliability and safety. Hence, HACCP is suggested to be applied in identifying and managing risks related to physical, chemical and biological hazards.

- Hazard Operability Analysis (HAZOP)

HAZOP works with the assumption theory that a series of risks occurs possibly by the design or operation deflection. HAZOP can also be categorized as a hazard identification technique by “guide-words” to identify possible deflection from the design. HAZOP is applicable to manufacturing processes, outsourcing production and formulation and evaluating hazard safety processes.

- Preliminary Hazard Analysis (PHA)

PHA is functioning by analyzing previous experiences or hazard knowledge to identify future hazards, harmful situations and the probability of occurrence. PHA is suitable to be applied in analyzing the existing system for production, manufacturing process and facility design.

Source: FDA

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