Recent Advances in Pharmaceutical Quality Risk Management Strategies and Tools
Prashant D Jadhav1*, Amol R. Pawar1,2*, Vikas V. Patil1, Pankaj S. Patil1
1Department of Quality Assurance, Kisan Vidya Prasarak Sanstha’s, Institute of Pharmaceutical Education, Boradi 425428.
2Research Scholar, Sankalchand Patel University, Visnagar – 384315, Gujarat, India.
*Corresponding Author E-mail:
ABSTRACT:
Risk management is a tool that is predictive and preventive rather than reactive.1 An essential tool for the pharmaceutical sector has been risk management. To maximize benefits and manage risks, QRM is a comprehensive and methodical approach to reducing risks to product quality across the course of its lifecycle. The Expert develops the ICH Q9 QRM. The pharmaceutical sector has been significantly impacted by the release of ICH Q9: Quality Risk Management.
The Q9 concepts are being implemented by the FDA and other regulatory agencies. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use's Expert Working Group (Quality) created ICH Q9 QRM, which outlines a model for a pharmaceutical quality system by offering guidelines and illustrations of quality risk management tools as well as a method for detecting, assessing, and managing potential quality risks in a scientific manner.2-3
Quality Risk Management:
The QRM system ensures that the assessment of quality risk is based on scientific understanding, process expertise, and ultimately patient preservation, and that the amount of work and documentation required for the QRM process is commensurate with the degree of risk. 3 Q9 ICH, 2006).4
PRINCIPALS OF QRM:
1. Scientific knowledge should be the basis for evaluating the danger to quality, which ultimately relates to patient protection.
2. The degree of risk should be reflected in the QRM process's input, formality, and documentation.
3. According to ICH Q9, the assessment concept makes up the four steps of an efficient QRM procedure. Each of the four elements—risk assessment, risk control, risk communication, and risk review—is crucial. Lotlikar (2013) and ICH (2005)4
QRM TOOLS:
Selecting the right tools or methodologies for risk assessment is a crucial first step in carrying out a risk analysis. There is no one best option for every particular assessment process; instead, the choice of the best risk methodology should be determined by the level of analysis needed, the complexity of the risk of interest, and the assessment tool's familiarity.4
Figure No: 1 Risk Management Tools4
PROCESS:
Quality risk management is a methodical procedure for evaluating, controlling, communicating, and reviewing risks related to the drug's (medical product's) quality during the course of its lifecycle.[3]Patients can be guaranteed the best quality drug product by using an efficient risk management strategy that offers tools to detect and address quality problems early in the product development process.[7]A model for quality risk management is outlined in the diagram (Figure 2).
Initiating a quality risk management process: 8
Quality risk management should include
· Describe the issue and/or risk question, mentioning any relevant presumptions that could indicate a risk.
· Compile background data and/or information about the possible danger, injury, or effect on human health that is pertinent to the risk assessment.
· Determine a leader and important assets.
· Give the risk management process a deadline, deliverables, and suitable degree of decision-making.
Figure No: 2 Overview of Quality Risk Management Process 4
1. Risk Assessment:7
The risk assessment process comprises of following three steps-
1. Risk identification,
2. Risk analysis
3. Risk evaluation.
The possible effects on patient safety, product quality, and risk awareness related to a risk question or problem statement should all be taken into consideration when determining the type and degree of rigor of a risk assessment.
Risk Identification: The process of methodically using data to find hazards in relation to the problem description is known as risk identification. Stakeholder concerns, theoretical analysis, historical data, and well-informed perspectives are all examples of information. For the objectives of a quality risk assessment, three basic questions are posed in order to precisely describe the risk or risks:
1) What might go wrong?
This query highlights the potential for injury from exposure to risks.
2) What is the likelihood (probability) it will go wrong?
This inquiry focuses on the likelihood that particular harms may occur.
3) What are the consequences (severity)?
This inquiry centers on the seriousness of the consequences, supposing that the risk event takes place.
Risk Analysis:
Analysis of Risk The evaluation of the risk connected to the hazards that have been discovered is known as risk analysis. It might be a qualitative or quantitative process that is related to the chance of an event occurring or the seriousness of the damages. The assessment of risk also takes into account the harm's detectability. When a multifunctional team of SMEs conducts risk analysis, it is advantageous. This guarantees that threats are examined from a variety of angles. Discussions within the team are very helpful in bringing to light various risk perceptions.
1. Risk evaluation: Risk evaluation involves comparing the detected and studied hazards to predetermined risk criteria. The results of a risk assessment might be either a qualitative description of a range of risks or a quantitative estimate of risk. In order to quantify risk, a numerical probability is employed. Another way to describe risk is with qualitative terms like "high," "medium," or "low." In order to award the rating more clearly, these descriptors should be stated in detail. Within quantitative risk assessments, a risk estimate indicates the probability of a particular outcome, given a collection of situations that pose a risk. Quantitative risk assessment is therefore helpful for a single outcome at a time.
2. Risk control: Risk control involves making decisions to reduce and accept risks. The goal of risk control is to bring the risk down to a manageable level.3 It operates on the premise that the effort placed on risk mitigation measures should be proportionate to the risk's importance. It also focuses on questions about:
1. It also emphasizes inquiries concerning
2. Techniques for lowering dangers
3. Potential for additional hazards as a result of managing an identified risk [9]
3. Risk reduction: As the name implies, risk reduction was concerned with lowering the risk from a particular point and reducing it below the generally recognized thresholds. Additionally, it should be mentioned that the system may experience new hazards or that pre-existing dangers may become more apparent. Thus, after choosing a risk reduction strategy, it is crucial to carry out risk assessment correctly to prevent unheard-of consequences. [9]
4. Risk acceptance: When risk control measures are implemented but long-term hazards are not addressed in the reactive conclusion, a formal decision to accept the long-term risk is made; this procedure is referred to as risk acceptance. Even the best QRM techniques may not completely eliminate a risk in some situations. In these situations, the QRM approach has been successfully applied, and it should be guaranteed that the risk is within an acceptable range. This acceptable level would rely on a number of factors.[10]
5.
Risk communication: The exchange of information on risk and risk
management between decision makers and other parties is known as risk
communication. Throughout the risk management process, parties can communicate
at any point.
The output or outcome of the quality risk management procedure needs to be
properly conveyed and recorded. Communications within a corporation, industry,
or regulatory body, as well as between industry and the patient or between
regulators and industry, may be considered communications. Other characteristics
of quality hazards may be included, such as their existence, nature, form,
probability, severity, acceptability, control, treatment, detectability, or
other elements. There is no requirement to communicate for every risk
acceptance. Decisions about quality risk management may be communicated between
the industry and regulatory bodies via the mechanisms already in place, as
outlined in rules and guidelines. [11]
6. Risk review: The process of quality management should include continuous risk management. It is necessary to put in place a system for reviewing or keeping track of events. It is important to examine the risk management process's output and outcomes in light of fresh insights and expertise. When a quality risk management process is started, it should be used for any events that could affect the initial decision about quality risk management, whether they are planned (such as the outcomes of product reviews, inspections, audits, and change control) or unplanned (such as root cause analysis). from recall and failure investigations). Any review's frequency ought to be determined by the degree of danger. Rethinking judgments about risk acceptance may be part of a risk review.
Applications of risk analysis tools and quality risk management:12
1. Clearly describe the product or procedure.
2. Divide the process or product into steps or parts.
3. Enumerate every potential cause of failure for every part or stage in the process.
4. Explain each failure mode's effects and assign a severity rating.
5. Determine which controls are in place to stop each cause from happening.
6. Analyze how well each control works to stop or identify failure modes.
7. Utilizing the formula RPN= (Severity x Occurrence x Detectability), determine the risk priority number (RPN).
8. Assign roles to carry out remedial actions and set deadlines for their fulfilment.
CONCLUSION:
Based on the assessment above, we can conclude that risk management is essential to pharmaceutical processes because it helps identify potential threats, offers solutions for overcoming risks, and reduces product non-conformities. In the pharmaceutical sector, cleaning procedure validation is crucial because it gives information about the effectiveness and consistency of cleaning techniques used to reduce residue deposits in manufacturing equipment. Simply put, a risk-based cleaning validation program integrates risk management into a company's cleaning validation process. By confirming the effectiveness of cleaning techniques, we can draw the conclusion that it will improve the product's quality and safety while also boosting overall readiness to face risks and possible threats.
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Received on 27.05.2025 Revised on 26.06.2025 Accepted on 16.07.2025 Published on 12.08.2025 Available online from August 18, 2025 Asian J. Research Chem.2025; 18(4):251-254. DOI: 10.52711/0974-4150.2025.00039 ©A and V Publications All Right Reserved
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