INTRODUCTION:

Quality: The design, development, in-process controls, Good Manufacturing Practice (GMP) controls, process validation, and requirements that are placed on drug substances and drug products as they are being manufactured all have an impact on the quality of these goods, according to ICH Q6A. This phrase is used to refer to traits like independence, power, and purity¹.

Quality system:

The sum of systems elements responsible for carrying out quality policy and guaranteeing the achievement of quality objectives.

Pharmaceutical quality system ICH Q10:

Based on ISO quality standards, the system addresses both ICH Q8 "Pharmaceutical Development" and ICH Q9 "Quality Risk Management". Standard Good Manufacturing Practises (GMP) norms have also been adopted².

Quality Management System in Pharmaceutical Industries:

A quality management system is made up of a variety of interconnected components that collaborate to guide an organization in accordance with predetermined protocols, regulations, resources, and objectives. The efficacy of the quality management system is maintained by taking into account all pertinent laws and regulations. Pharmaceutical businesses benefit from improved product quality and fewer products recall risk thanks to quality management systems³.

The development of a process-based quality management system inside an organisation depends on many variables, including quality objectives, quality policies, also effective risk management. Pharmaceutical organisations must focus on internal effectiveness and consumer demands in order to continue operating successfully in light of the significant changes the pharmaceutical business has lately seen. For the benefit of public health, the quality management system encourages a thriving pharmaceutical sector to improve the standard and accessibility of medicines around the world^4,5.

To the industry and regulatory organisations, the pharmaceutical quality management system provides as evidence of this. Through the control of quality management systems, organisations foster innovation, continuous improvement, and a stronger connection between the research and development of pharmaceuticals and the manufacturing of such drugs^6,7.

In terms of improving the pharmaceutical quality system, identifying and prioritising product quality, and regularly exceeding the requirements set by drug producers, the pharmaceutical industry is always evolving. The quality management system used by the pharmaceutical business helps create an effective monitoring system based on output and product quality⁸.

The system also ensures that procedures that are useful in locating monitoring and regulating systems continue to be suitable and capable. The system was developed to meet the needs of regulated companies engaged in the biosciences. Thanks to the control of quality management systems, businesses everywhere successfully streamline, automate, and manage their processes. In the end, it is the pharmaceutical company's job to make sure that procedures are in place to guarantee the calibre of purchased services and the administration of operations that are outsourced⁹.

The cornerstone of the crucial laws governing the pharmaceutical industry is the quality management system. Pharmaceutical firms must create a product and its manufacturing process in order to continuously meet the needs of patients and medical professionals while also delivering the desired results. These methods communicate product and production process knowledge between product development and manufacturing in order to maximise product utilisation. Businesses create drug substance and drug product control strategies to support both immediate and efficient corrective action as well as preventive activity^10,11.

This tactic is effective. The pharmaceutical sector must comprehend the causes of variation that affect process presentation and product quality in order to develop feasible improvement methods to eliminate variation. The pharmaceutical industry today has access to measurements and analytical measuring techniques thanks to quality management systems. A rigorously designed plan for process presentation and product superiority that also identifies areas for improvement ensures the pharmaceutical industry's success¹².

Continuous scale-up monitoring will enable successful integration into manufacturing and a presentation of the preliminary sign-off procedure. Ideally, scale-up activities and knowledge gained at some point throughout the transfer should be used to enhance the control policy. Pharmaceutical companies continue to conduct product stability testing in accordance with the guidelines established by their quality management systems^13,14.

The pharmaceutical industry's quality management systems have changed as a result of a review of the marketing authorization and the incorporation of pertinent experience and information from related fields. The size of the organisation affects the level of management and the timeliness of communication when bringing up related quality issues. The pharmaceutical industry employs the quality management system to methodically coordinate and record actions. As a result, it is simpler to maintain consistency in performance, and the conclusion is more suitable¹⁵. The main goal of the quality management system is to support the pharmaceutical industry's short- and long-term goals as well as the quality manual's accomplishment. A clear line of communication is established and maintained through the procedures, ensuring that the client's needs are well comprehended. Management evaluations were employed in the pharmaceutical sector to rate the product's stability and quality^16,17.

In the pharmaceutical sector, quality management systems are used to support design and development and ensure that the finished product meets the established criteria. By creating and upholding written procedures, the industry may confirm and regulate the product's conception and development.

Periodic meetings to compare design validation and verification are recommended by the quality management system plan. During the development of a pharmaceutical product, stability testing can help¹⁸.

The pharmaceutical industry focuses on resolving and preventing internal problems through its quality management system. It should go without saying that saving money by averting issues before they arise so it is anticipated that biological products will have a wide range of production by products and a built-in lack of predictability. The pharmaceutical industry audits its operations using quality management system concepts. Before releasing the goods, the manufacturer must inspect and test the source. The manufacturer's quality management system should provide coverage for management control of the client-supplied product quality. The contract supplier and contract acceptor should have a documented and authorised contract specifying each party's responsibilities at each stage^19,20.

The consumer must also offer things that can be positively identified. Before handling the items cautiously to prevent harm, they should first be inspected to ensure their quality. As part of the steps necessary to build a quality management system in the pharmaceutical industry, a variety of indicators have been monitored and regulated to make sure the process is operating as intended by the process design^21,22.

Quality Risk Management:

Many corporate and governmental sectors, including banking, insurance, workplace safety, public health, and pharmacovigilance, have effectively implemented risk management concepts. The organisations in charge of these risk management programmes in the pharmaceutical sector, however, are under pressure and do not fully account for the potential benefits of risk management. Pharmaceutical firms recognise the value of quality systems, and It is now more obvious than it ever was before that quality risk management is an essential part of an efficient quality system²³.

Most people are aware that risk results from the interaction between the possibility of injury and the seriousness of the injury. The threat that it poses to its own quality is one aspect of the whole hazard. It is of the utmost importance to realize that product quality should be maintained over the three-product lifespan in order to guarantee that the characteristics required for the medicine (medicinal) product's quality stay consistent with those utilized in the clinical research. In other words, it is essential to realize that product quality should be maintained over the three-product lifespan^24,
25.

Scope:

This recommendation provides best practises for quality risk management as well as practical tools that can be used to handle a variety of pharmaceutical quality challenges. The phases of creating, distributing, inspecting, submitting, and assessing biological and biotechnological products, as well as drug substances and drug (medicinal) products, are all covered by these processes. Excipients, packaging, labelling, raw ingredients, solvents, and packaging are all covered²⁶. They also apply to biological and biotechnological goods.

Quality Risk Management Principles:

The following is an outline of the first two primary essential tenets of effective risk management:

The approach to quality risk management should involve the same level of formality, paperwork, and effort as the level of risk, and the risk to quality assessment should be supported by data from scientific studies that eventually safeguard patients^27,28.

General Quality Risk Management Procedure:

The term "quality risk management" refers to the process of systematically identifying, mitigating, debating, and analyzing potential threats to the safety and efficacy of a drug (or any other type of medicinal product) at any point in the product's lifetime. This can include any phase of the product's development. Figure 1 provides a nice illustration of risk management. It is possible to use different models²⁹. Each issue will be examined in the appropriate depth for the particular risk in a competent process, and each component of the framework may be given a different weight depending on the situation.

Because decisions can be made at any point throughout the process, the model that came before this one does not contain any decision nodes. Some options include going back to the prior step and gathering more information, modifying the risk models, or perhaps giving up on the risk management plan altogether, if the data justifies such a move. Please keep in mind that the phrase "unacceptable" in the flowchart suggests that the risk assessment approach and any applicable legal, legislative, or regulatory requirements should be reviewed^30,31.

Responsibilities:

Risk management tasks are often, but not always, carried out to a high standard by interdisciplinary teams. Individuals with prior experience utilizing the quality risk management approach should be included on teams, in addition to specialists from comparable fields (such as quality unit, business development, engineering, regulatory affairs, manufacturing operations, sales and marketing, legal, statistics, and clinical)³².

Decision maker should:

Assume responsibility for the coordination of high-quality risk management across the many activities and divisions of the organization. Make that a solid risk management plan is developed, put into action, and reviewed³³.

Figure 1: strategy to management of quality risks that are standardized.

Procedure of quality risk management:

The process of making decisions based on risks ought to be systematically improved upon, coordinated, and improved upon as part of any good risk management program. The actions and steps outlined below might serve as a starting point for developing and planning an effective risk management strategy:

1. Specify the problem and/or risk in question, drawing any necessary inferences to identify any potential hazards.

2. Gather background information and/or information on the potential dangers, damages, or effects on human health identified in the risk assessment.

3. Select a leader and the resources required.

4. Determine the timeframe for the risk management process, as well as its deliverables and the appropriate decision-making level³⁴.

Risk Assessment:

Once risks have been identified, they are investigated and any potential hazards are assessed (as stated below). A particular problem description or risk inquiry is the initial stage in any efficient risk assessment. If the risk has been clearly characterized, it will be much easier to select a risk management system that is operational, as well as the categories of information that are required to handle the risk concern³⁵.

Risk identification:

To discover threats that match to a risk question or problem description, careful data utilisation is required. There are many different types of information, such as theoretical analyses, well-informed viewpoints, stakeholder concerns, and historical facts. Finding probable consequences is one step in replying to the question. In terms of potential hazards, ask yourself, "What could go wrong?" New phases in the quality risk management procedure may also be added³⁶.

Risk Analysis:

Involved in determining the risks associated with the identified risks. Injury severity and likelihood of occurrence can be linked using both qualitative and quantitative measures. Some risk management strategies assess the risk while taking into account the detectability of the harm³⁷.

Risk Evaluation:

Examines and compares the discovered and assessed dangers to approved risk standards. When analysing risks, the veracity of the evidence used to support each of the three basic issues is considered.

A risk assessment will produce either a numeric risk estimate or a qualitative description of a risk spectrum. Both of these outcomes are possible. When calculating risk, quantitative likelihood is the method of choice. "High," "medium," and "low," which are alternative qualitative terms for hazard, should be explained in detail. Consider using the phrase "risk score" to describe risk ranking characteristics in a more precise manner. A risk estimate is a representation, within the context of a quantitative risk assessment, of the likelihood of a particular result given a set of risk-generating variables. As a result, the use of quantitative risk estimation for just one outcome at a time is strongly recommended. Another choice is a relative risk metre, which evaluates relative risk while taking varying levels of seriousness and possibility into account. Quantitative risk computation may occasionally be incorporated into a scoring method's intermediate processes³⁸.

1. Risk control: Making judgments about taking or avoiding risks is a part of risk management. The reduction of risk to a manageable level is the aim of risk control. Depending on the level of risk, different amounts of effort need be placed into risk management. The optimal level of risk control can be determined by decision-makers using a variety of techniques, such as benefit-cost analysis³⁹.

The following inquiries could be the focus of risk management:

· Is the danger at an unacceptably high level?

· How can risks be reduced or eliminated?

· How should resources, risks, and advantages be distributed?

· Has the treatment of the identified concerns led to the emergence of additional risks?

Risk reduction concentrates on methods for high-quality risk mitigation or avoidance when a risk exceeds a current (acceptable) threshold (see Figure 1). A strategy for reducing risks can comprise taking measures to lessen the impact of potential injuries and cut down on the number of times they occur. Practises that make risks and quality issues obvious may also be part of a risk control plan. Strategies for risk mitigation could exacerbate current issues or introduce new threats into the system. In order to identify and evaluate any potential changes in risk, it can be smart to review the risk assessment after implementing a risk reduction plan ⁴⁰. Choosing to take a chance is known as accepting a risk. Either formally decide to accept the lingering risk or passively decide without bringing up the pertinent risks. It is possible that even the most effective risk management measures will not be able to completely remove all of the dangers associated with certain categories of injuries. In these types of scenarios, it is possible to reach the conclusion that an effective plan for managing the quality risk has been implemented, and that the quality risk has been brought down to a level that is seen to be acceptable. After carefully weighing all relevant criteria, it is better to separately select this (specified) acceptable quantity ⁴¹.

2. Risk communication: Having knowledge of risk management should be a must for everybody who makes decisions involving risk. The risk management method (see Figure 1: dashed arrows) makes it possible for stakeholders to stay in constant communication with one another. An excellent risk management strategy's output or result must be clearly stated and recorded (see Figure 1's solid arrows). Interactions between interested parties, including those that are a part of a given industry, business, or regulatory body, as well as those that take place between regulators and the private sector, the public sector, and so on, may be covered ⁴². We can have a conversation on the existence, nature, manifestation, tendency, severity, acceptability, control, remedy, detectability, and any other aspect of the quality hazards. It is not required to communicate for the acceptance of each and every danger. The present legal and regulatory frameworks enable industry and regulatory organisations to consult on prudent risk management decisions ^{43, 44}.

3. Risk Review: The strategy for quality management should include continuous risk management as one of its components. There must be a system in place for either reviewing past occurrences or documenting new ones ^{45, 46}. It is essential to have a look at the output and outcomes of the risk management process in order to make sure that you are taking into account the most recent information and experiences. Once the quality risk management process has been initiated, any upcoming events, whether they are planned or unplanned (such as the outcomes of product reviews, inspections, audits, or change control), that may have an impact on the initial quality risk management decision (such as the root causes of failure investigations, recalls), should be managed through it ⁴⁷. This includes any events that may have an effect on the initial quality risk management decision. It is important to base the frequency of any examination on the level of risk that is present. The decision to take a risk, or not, might be based on the results of a risk analysis ^{48, 49}.

RISK MANAGEMENT METHODOLOGY:

An approach to decision-making that is rational, grounded in practice, and founded in science is bolstered by effective risk management ⁵⁰. It provides processes that are stated, understandable, and reproducible for carrying out the steps of the quality risk management process. These processes are based on the most recent studies that have been conducted on analyzing the frequency, severity, and occasionally detectability of the risk^51,52. In the past, informal methods (empirical and/or internal procedures) were used to analyze and address quality issues. These methods were based on, for instance, the compilation of observations, trends, and other information^53,54. These methods continue to deliver enlightening information that may be put to use to solve issues relating to variety, quality, resource allocation, and complaint handling^55,56. The pharmaceutical industry and regulators are both able to undertake risk research and manage risk if they make use of internal processes (such as standard operating procedures) and/or well-known risk management methodologies^57-60.

CONCLUSION:

Students should study the pharmaceutical quality system to learn about the standards of various sectors. We should investigate quality risk management and the ICH recommendations thoroughly because they may be advantageous to us. Studying pharmaceutical quality assurance programmes aids in the development of processes and their structure in order to meet standards. These studies boost the company's standard of excellence and effectiveness, while also helping to improve the quality, effectiveness, and patient safety of pharmaceutical goods.

ABBREVIATIONS:

QMS: Quality Management System

GMP: Good Manufacturing Practice

Q10 : Pharmaceutical Quality System

Q9 : Quality Risk Management

ICH : International Council on Harmonisation

ACKNOWLEDGEMENT:

The authors would like to thank the Principal and Secretary of Shreeshakti Shaikshanik Sanstha’s Divine College of Pharmacy, Satana, Nashik, India.

CONFLICT OF INTEREST:

No conflict of interest.

DATA AVAILABILITY STATEMENT:

All required data is available.

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Received on 25.12.2024 Revised on 01.03.2025

Accepted on 11.04.2025 Published on 06.05.2025

Available online from May 10, 2025

Asian Journal of Pharmaceutical Analysis. 2025; 15(2):146-152.

DOI: 10.52711/2231-5675.2025.00023

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