Pharmaceuticals

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

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By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.

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ICH is a consensus-driven process that involves technical experts from regulatory authorities and industry parties in detailed technical and science-based harmonization work that results in the development of ICH guidelines.

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Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries.

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In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators.

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The importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective quality system.

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It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.

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An effective quality risk management approach can further ensure the quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development, manufacturing, and distribution.

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This includes an appropriate application of root cause analysis that can identify and address the root cause(s) and other causal factors (e.g., human-related) of such issues.

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A proactive approach to quality risk management is beneficial, as it facilitates robust product design and continual improvement, and it is of strategic importance in achieving an effective pharmaceutical quality system (see the International Council for Harmonisation (ICH) guidance for industry Q10 Pharmaceutical Quality System (ICH Q10) (April 2009)3 for guidance in relation to an effective pharmaceutical quality system).

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In the development phase and as part of validation, quality risk management is part of building knowledge and understanding risk scenarios, so that appropriate risk control can be decided upon for use during the commercial manufacturing phase.

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An understanding of formality can also support risk-based decision-making, where the level of formality that is applied may reflect the degree of importance of the decision, as well as the level of uncertainty and complexity which may be present.

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Appropriate use of quality risk management can facilitate but does not obviate industry’s obligation to comply with regulatory requirements and does not replace appropriate communications between industry and regulators.

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Quality risk management should not be used in a manner where decisions are made that justify a practice that would otherwise, in accordance with regulations and/or guidance, be deemed unacceptable.

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Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

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These decisions might be to return to the previous step and seek further information, to adjust the risk models or even to terminate the risk management process based upon information that supports such a decision.

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Responsibilities (4.1) Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams.

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When teams are formed, they should include experts from the appropriate areas (e.g., quality unit, product development, business development, engineering, regulatory affairs, production operations, sales and marketing, supply chain, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process.

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Initiating a Quality Risk Management Process (4.2) Quality risk management should include systematic processes designed to coordinate, facilitate and improve science-based decision-making with respect to risk.

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When the risk in question is well defined, an appropriate risk management tool (see examples in section V (5)) and the types of information needed to address the risk question will be more readily identifiable.

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Hazard identification is a systematic use of information to identify hazards referring to the risk question or problem description.

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In doing an effective risk assessment, the robustness of the data set is important because it determines the quality of the output.

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Revealing assumptions and reasonable sources of uncertainty will enhance confidence in this output and/or help identify its limitations.

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The output of a risk assessment is either a quantitative estimate of risk or a qualitative description of a range of risk.

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Alternatively, risk can be expressed using qualitative descriptors, such as “high,” “medium,” or “low,” which should be defined in as much detail as possible.

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Processes that improve the detectability of hazards and quality risks might also be used as part of a risk control strategy.

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The implementation of risk reduction measures can introduce new risks into the system or increase the significance of other existing risks.

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Hence, it might be appropriate to revisit the risk assessment to identify and evaluate any possible change in risk after implementing a risk reduction process.

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Risk Communication (4.5) Risk communication is the sharing of information about risk and risk management between the decision makers and others.

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While detectability may not be a discrete factor in some quality risk management methods, detection controls are important as they can reduce the probability of occurrence of harm.

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Traditionally, risks to quality have been assessed and managed in a variety of ways (empirical and/or internal procedures) based on, for example, compilation of observations, trends, and other information.

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Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations, and allocation of resources.

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Formality in Quality Risk Management (5.1) Formality in quality risk management is not a binary concept (i.e., formal/informal); varying degrees of formality may be applied during quality risk management activities, including when making risk-based decisions.

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Systematic approaches for acquiring, analyzing, storing, and disseminating scientific information are essential for generating knowledge, which in turn informs all quality risk management activities.

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Uncertainty may be reduced via effective knowledge management, which enables accumulated and new information (both internal and external) to be used to support risk-based decisions throughout the product lifecycle.

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Importance: The more important a risk-based decision may be in relation to product quality, the higher the level of formality that should be applied, and the greater the need to reduce the level of uncertainty associated with it.

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Complexity: The more complex a process or subject area is to a quality risk management activity, the higher the level of formality that should be applied to assure product quality.

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Risk-Based Decision-Making (5.2) Risk-based decision-making is inherent in all quality risk management activities; it provides an essential foundation for decision makers in an organization.

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Effective risk-based decisionmaking begins with determining the level of effort, formality and documentation that should be applied during the quality risk management process.

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The decisions made from quality risk management activities include those in relation to what hazards exist, the risks associated with those hazards, the risk controls required, the acceptability of the residual risk after risk controls, and the communication and review of quality risk management activities and outputs.

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(See section V.A (5.1) above for guidance on what constitutes formality in quality risk management.) Higher levels of formality in quality risk management may require higher levels of structure in relation to risk-based decision-making.

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Managing and Minimizing Subjectivity (5.3) Subjectivity can impact every stage of a quality risk management process, especially the identification of hazards and the estimation of probability of occurrence and severity of harm.

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While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled by addressing bias and assumptions, the proper use of quality risk management tools and maximizing the use of relevant data and sources of knowledge (see ICH Q10, section II.E.1 (1.6.1)).

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Training of both industry and regulatory personnel in quality risk management processes provides for greater understanding of decision-making processes and builds confidence in quality risk management outcomes.

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The Role of Quality Risk Management in Addressing Product Availability Risks Arising From Quality/Manufacturing Issues (6.1) Quality/manufacturing issues, including non-compliance with Good Manufacturing Practice (GMP), are a significant cause of product availability issues (e.g., product shortages).

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When risk-based drug shortage prevention and mitigation activities are performed, the level of formality that is applied to those activities may vary (see section V.A (5.1)) and should be commensurate with the level of risk associated with a loss of availability of the product(s).

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A successful manufacturing partnership is strengthened by appropriate communication and collaboration mechanisms (See section II.G (2.7) of ICH Q10).

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Hazard Identification: The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.

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Quality System: The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.

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Stakeholder: Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk.

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For the purposes of this guideline, the primary stakeholders are the patient, healthcare professional, regulatory authority, and industry.

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Failure Mode Effects Analysis (FMEA) (I.2) FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance.

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Failure Mode, Effects, and Criticality Analysis (FMECA) (I.3) FMEA might be extended to incorporate an investigation of the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability, thereby becoming a Failure Mode Effect and Criticality Analysis (FMECA; see IEC 60812).

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Fault Tree Analysis (FTA) (I.4) The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process.

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Hazard Analysis and Critical Control Points (HACCP) (I.5) HACCP is a systematic, proactive, and preventive tool for assuring product quality, reliability, and safety (see WHO Technical Report Series No 908, 2003 Annex 7).

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Hazard Operability Analysis (HAZOP) (I.6) HAZOP (see IEC 61882) is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions.

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Preliminary Hazard Analysis (PHA) (I.7) PHA is a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product, or system.

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The tool consists of: (1) the identification of the possibilities that the risk event happens; (2) the qualitative evaluation of the extent of possible injury or damage to health that could result; (3) a relative ranking of the hazard using a combination of severity and likelihood of occurrence; and (4) the identification of possible remedial measures.

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It can be used for product, process, and facility design as well as to evaluate the types of hazards for the general product type, then the product class, and finally the specific product.

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Typically, hazards identified in the PHA are further assessed with other risk management tools such as those in this section.

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This Annex is intended to identify potential uses of quality risk management principles and tools by industry and regulators.

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However, the selection of particular risk management tools is completely dependent upon specific facts and circumstances.

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Change Management/Change Control To manage changes based on knowledge and information accumulated in pharmaceutical development and during manufacturing; To evaluate the impact of the changes on the availability of the final product; To evaluate the impact on product quality of changes to the facility, equipment, material, manufacturing process or technical transfers; To determine appropriate actions preceding the implementation of a change, e.g., additional testing, (re)qualification, (re)validation or communication with regulators.

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Hygiene Aspects in Facilities To protect the product from environmental hazards, including chemical, microbiological, and physical hazards (e.g., determining appropriate clothing and gowning, hygiene concerns); To protect the environment (e.g., personnel, potential for cross-contamination) from hazards related to the product being manufactured.

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Quality Risk Management as Part of Materials Management Assessment and Evaluation of Suppliers and Contract Manufacturers (II.5) To provide a comprehensive evaluation of suppliers and contract manufacturers (e.g., auditing, supplier quality agreements).

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Quality Risk Management as Part of Production Validation (II.6) To identify the scope and extent of verification, qualification, and validation activities (e.g., analytical methods, processes, equipment, and cleaning methods); To determine the extent for follow-up activities (e.g., sampling, monitoring and re-validation); To distinguish between critical and non-critical process steps to facilitate design of a validation study.

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Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.

python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom018_t07_primary_claims.json --source-file <local-raw-pdf>

Quality Risk Management as Part of Laboratory Control and Stability Studies Out of Specification Results (II.7) To identify potential root causes and corrective actions during the investigation of out of specification results.

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Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.

python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom018_t07_primary_claims.json --source-file <local-raw-pdf>

Quality Risk Management as Part of Supply Chain Control (II.9) Regarding product availability risks related to quality/manufacturing issues, product lifecycle oversight of the supply chain includes maintaining current knowledge of quality/manufacturing hazards and prioritizing efforts to manage such risks.

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Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.

python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom018_t07_primary_claims.json --source-file <local-raw-pdf>

Manufacturing Facilities and Equipment To ensure that facility infrastructure and equipment are suitable and designed for robust manufacturing (this includes packaging and testing) (see Annex II.4); To establish facility and equipment maintenance programs that assure reliable facility and equipment performance; To ensure that the operational design of equipment is not vulnerable to human error; To obtain quality and efficiency gains through the utilization of digitalization, automation, isolation technology, and other innovations.

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Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.

python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom018_t07_primary_claims.json --source-file <local-raw-pdf>

Supplier Oversight and Relationships To enhance review and monitoring activities (see section III.G (2.7) of ICH Q10) when substantial variability is identified in the quality and safety of supplied materials or in the services provided.

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