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By - Kossi Molley (he/il)

Quality Risk Management in Pharma

As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle [1]. In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks [2].

International Society for Pharmaceutical Engineering (ISPE) on GAMP5® Guidance defines Quality Risk Management Approach as a systematic process for the assessment, control, communication, and review of risks. Quality risk management should be applied both proactively and retrospectively.

The principles of quality risk management are that:

  • The evaluation of the risk to quality is based on scientific knowledge and experience with the process, and ultimately links to the protection of the patient.
  • The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.

Examples of quality risk management processes and applications can be found in ICH Q9: Quality Risk Management.

System Risk Assessment

Through System Risk Assessment, Pharma project team shall evaluate and access the product quality risk for direct impact systems as determine through system Classification. This assessment is a team and cross-functional activity where system SME’ shall play a key roles as they know and understand very well the process and related product critical quality attributes (CQAs).

The typical key elements that need to be reviewed and assessed are:

  • Different operations sequence
  • Process description
  • Product CQAs
  • Critical process parameters
  • Description of how CQAs can be impacted
  • Design control
  • Procedural control 

As part of this assessment, only in-operation state of the process shall be considered as the start-up and shutdown conditions have minor impact from quality perspective.

Quality Risk Assessment

The quality risk assessment is an iterative process performed from the design stage of process through its development. Performing quality risk assessment means applying the risk management life cycle as shown in figure 1: Quality Risk Management Life cycle.

Fig.1: Quality Risk Management Life Cycle

The objective of risk Identification is to develop a comprehensive analysis that includes all applicable operations. This stage of risk assessment shall be taken with care to include all systems and operations that could be simply perceived as low risk. The Risk Analysis estimates the potential harm(s) associated with each potential risk. The analysis could be qualitative or quantitative in nature, or a combination of the two.

Risk Management Methods and Tools

Various risk methods and tools are available and can be utilized to assess product and process risk. The following are the type of risk that Pharma Manufacturer could face to:

  • Patient risk ( safety of products)
  • Manufacturing and operational risk (operation safety and process variability)
  • Product quality risk (API, excipients, starting material non-compliance)
  • Financial risk (product loss, reputation, and legal cost)
  • Regulatory risk ( product recall, loss of Health Canada licence, seizure and legal actions)
  • And so forth,

There is no one risk method or tool which can fit all type of risks. Depending on the type of risk, the choice of the risk analysis tool should be appropriate in order to minimize process risk. For example Failure Mode Effects Analysis (FMEA) will be use to analyze a manufacturing process risk but may not be suitable for process safety hazards evolution.

Potential Applications for Quality Risk Management

The Table 1 is provided to show some areas where Quality Risk Management can be applied. The purpose of this table 1 is for illustration only and is not intended to create any new expectations with regard to Regulatory Requirements.

Table 1: Areas of Potential Application for Quality Risk Management

However, adopting Quality Risk Management framework and principles in day-to-day business can help your organization in four (4) different ways [3] :

  • Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk;
  • Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment;
  • Identify a leader and necessary resources;
  • Specify a timeline, deliverables and appropriate level of decision making for the risk management process.


  • GUI-0001: Good Manufacturing Practices Guides for Drug Product, health Canada, Published on July 2020
  • ICH Q9: Quality Risk Management

About the authorKossi Molley, PMP., LSSBB., Chemist

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