Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
Medicinal products must be of consistently high quality and readily available. Regulatory setbacks, product recalls, and compromised patient safety can result from a lack of an effective quality management system, making these tasks even more challenging.
The ICH Q10 Pharmaceutical Quality System (PQS) offers a robust framework designed to address these challenges head-on. By implementing ICH Q10, pharmaceutical companies can streamline their processes, enhance product quality, and ensure compliance with regulatory standards and the requirements defined in the marketing authorization, throughout the entire product lifecycle.
Consider a scenario where your organization transitions smoothly from pharmaceutical development to technology transfer to commercial manufacturing to product discontinuation while maintaining impeccable quality and regulatory compliance at each stage of the product lifecycle. With ICH Q10, this vision can become a reality.
Implementing the ICH Q10 PQS is not just a regulatory necessity but a strategic move toward achieving excellence in pharmaceutical manufacturing.
To navigate this journey effectively, leveraging an electronic Quality Management System (eQMS) can be transformative. An eQMS not only simplifies the implementation of ICH Q10 but also addresses the challenges of manual processes.
In this article, you will learn all about the ICH pharmaceutical guidelines. You will discover the principles of ICH Q10, how to implement ICH Q10 PQS, and how adopting an eQMS can help your organization adhere to ICH Q10 guidelines, improve operational efficiency, and ultimately deliver high-quality products that meet patient needs.
And if you'd like to discover how to build a pharmaceutical QMS in more detail and learn about regulations such as ICH Q9 quality risk management, we invite you to discover our QMS in pharma guide!
What is the ICH Q10 Pharmaceutical Quality System?
ICH Q10 Pharmaceutical Quality System (PQS) is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceutical Use (ICH).
This guideline offers a unified model designed to enhance and clarify existing regulations. It aims to shift from traditional Good Manufacturing Practice (GMP) compliance at various product lifecycle stages to a holistic, modern quality management system that fosters innovation and continuous improvement.
Recommended learning: Explore our guide on the 5 main components of GMP to ensure continuous compliance.
Applicable to any company involved in the development and manufacture of active pharmaceutical ingredients (APIs) and drug products, including biotechnology and biological products, ICH Q10 is an integral part of a tripartite framework that includes ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management).
ICH Q10 outlines a model for an effective Pharmaceutical Quality System grounded in ISO quality principles and relevant GMP regulations. It complements ICH Q8, which guides pharmaceutical development, and ICH Q9, which offers quality risk management tools and principles.
A significant feature of the PQS is its applicability to the manufacture of investigational products, as regional GMPs apply here as well. Refer to Figure 1 for an overview of the various lifecycle stages, elements, and enablers within the PQS model.
What is the ICH Q10 Pharmaceutical Quality System?
The ICH Q10 guidelines are built around three primary objectives:
Objective 1: Achieve Product Realisation
Product realization is about delivering safe, effective, and high-quality pharmaceutical products to the market.
ICH Q10 emphasizes the need for a systematic approach to product development, manufacturing, and quality control to ensure that every product meets its intended quality attributes.
Objective 2: Establish and Maintain a State of Control
Maintaining a state of control involves consistently producing products that meet their specifications and quality standards.
This guideline helps pharmaceutical companies develop and utilize effective monitoring and control systems, ensuring manufacturing process suitability, performance, and consistent product quality, to prevent deviations and ensure compliance.
Objective 3: Facilitate Continual Improvement
Continual improvement. focuses on enhancing product quality and operational efficiency over time.
ICH Q10 promotes identifying and implementing opportunities for innovation, improving processes and product quality, minimizing variability, and enhancing pharmaceutical quality systems.
ICH Q10 Enablers
The ICH Q10 Pharmaceutical Quality System (PQS) is supported by two key enablers: Knowledge Management and Quality Risk Management (QRM). These enablers facilitate the implementation of Pharmaceutical Quality System Elements and enable science- and risk-based decisions throughout the product lifecycle.
Knowledge Management
Knowledge Management involves the systematic process of capturing, analyzing, storing, and sharing information about products, manufacturing processes, and other organizational components.
This ensures that knowledge gained during development and manufacturing is accessible and used to improve processes and prevent issues.
Quality Risk Management
Quality Risk Management (QRM) is a structured tool for the proactive assessment, control, communication, and review of potential risks that could impact product quality during development and manufacturing.
This systematic approach involves identifying, analyzing, and evaluating risks to ensure product quality and compliance throughout the lifecycle. By integrating QRM, organizations can better anticipate and mitigate risks, ensuring consistent product quality and safety.
ICH Q10 Life Cycle Stages & Goals
ICH Q10 PQS applies to four key stages of a product’s lifecycle: pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. Each stage has specific goals and technical activities.
Pharmaceutical Development
In this stage, the focus is on designing products and processes that consistently deliver the intended drug performance and meet the needs of patients, healthcare professionals, regulatory authorities, and other key stakeholders.
This stage leverages tools like quality-by-design (QbD), process analytical technology (PAT), and risk-based approaches to ensure product safety and efficacy.
Key activities include:
- Drug substance development
- Drug formulation development
- Manufacture of investigational products
- Manufacturing process development and scale-up
- Analytical method development
Technology Transfer
Technology transfer involves transferring product and process knowledge from development to manufacturing, and between manufacturing sites, ensuring consistent and quality-controlled production. This transfer standardizes processes, reduces development time and costs, and prevents production issues.
Key activities include:
- New product transfers during development to manufacturing
- Transfers within or between manufacturing and testing sites for marketed products
Commercial Manufacturing
Commercial manufacturing is the production phase, where maintaining a state of control is vital. The goals are to achieve product realization, maintain a state of control, and promote continuous improvement.
Maintaining control ensures consistent quality by monitoring process parameters, materials, equipment, and personnel. Continuous improvement identifies and addresses inefficiencies, reduces waste, and optimizes processes.
Key activities include:
- Materials procurement and control
- Provision of facilities, utilities, and equipment
- Manufacturing operations
- Quality control and quality assurance
- Product release
- Storage
- Distribution
Product Discontinuation
Discontinuation should be planned well in advance. Even when discontinuing a product, quality remains important. The goal is to efficiently manage the end of your product’s lifecycle.
This involves adhering to regulatory requirements for reporting and notifications, retaining relevant documentation and samples, and continuing product assessments. Monitoring discontinued products ensures compliance with expiration dates and addresses any ongoing issues.
Key activities include:
- Document retention
- Sample retention
- Continued product assessment and reporting
- Periodic reporting to authorities
Pharmaceutical Quality System Elements
The ICH Q10 PQS is built on four core pillars, essential for supporting each stage of the product lifecycle:
- Process performance and product quality monitoring system
- Corrective and preventive action (CAPA) system
- Change management system
- Management review of process performance and product quality
These elements should be applied appropriately and proportionately to each lifecycle stage, recognizing that each stage has unique goals and varying levels of available knowledge.
By tailoring these PQS elements to the specific needs and characteristics of each stage, organizations can ensure robust quality management throughout the product lifecycle.
How to implement the ICH Q10 Quality Management System model
Implementing the ICH Q10 Pharmaceutical Quality System model involves several key steps:
Understand the scope and objectives of ICH Q10
Begin by comprehensively understanding the ICH Q10 requirement, understanding its objectives, and how it applies to your organization. This foundational knowledge will guide your implementation efforts. Focus on its three main objectives: achieving product realization, maintaining a state of control, and facilitating continual improvement.
Conduct a gap analysis
Conduct a gap analysis of your current quality management system against the ICH Q10 requirements. Identify gaps and areas needing improvement. This analysis will help you prioritize actions and allocate resources effectively.
Develop the implementation plan
Develop a comprehensive implementation plan, including the steps required to address the identified gaps. Include timelines, responsibilities, training requirements, and resources needed for each step.
Establish and document the PQS
Document your Pharmaceutical Quality System, including quality policies, quality objectives, procedures, and processes. Ensure that all elements of the ICH Q10 guideline are covered and that the documentation is accessible and up-to-date.
This includes establishing a comprehensive quality plan.
Engaging employees and management throughout the PQS lifecycle is one of the most effective ways to foster widespread commitment to quality.
This engagement can be facilitated through regular training sessions, workshops, and open forums where employees can contribute their insights and feedback.
Furthermore, senior management plays a pivotal role in championing quality within the organization. They should lead by example, consistently emphasize the importance of quality and the PQS, and offer unwavering support when needed.
Senior management is also accountable for overseeing the effective implementation of the PQS to achieve established quality objectives. This includes management review and resource management.
To ensure accountability and alignment throughout the organization, roles, responsibilities, and authorities must be clearly defined.
Implement the PQS
Put your documented quality system into practice. Train employees, implement processes, and establish monitoring and reporting mechanisms to ensure adherence to the PQS.
Leverage the ICH Q10 enablers
Utilize knowledge management to handle product and process knowledge throughout the product lifecycle. Employ science-based and risk-based decision-making principles and tools to enhance quality management.
Apply Pharmaceutical Quality System elements across the lifecycle stages
Ensure that the PQS is integrated across all stages of the product lifecycle. From development to discontinuation, maintain quality standards and control to ensure product safety and efficacy.
Tailor the application of PQS elements to the specific goals and knowledge available at each lifecycle stage, including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation.
Ensure appropriate resource allocation and communication
Allocate sufficient resources to implement and sustain the PQS, including personnel, technology, and budget. Establish effective internal communication processes to support PQS activities, ensuring all relevant information is shared and understood across the organization.
Establish a Robust Management Review Process
Regularly review the performance of your PQS through management reviews. Use these reviews to assess effectiveness, identify improvement opportunities, and make informed decisions.
Ensure senior management takes responsibility for implementing an effective PQS. This includes clearly defining and communicating roles and responsibilities, actively participating in the PQS's design, and implementation, defining performance indicators, monitoring, and maintenance, ensuring timely communication and escalation of quality issues, conducting management reviews, advocating continual improvement, and committing necessary resources.
Scilife tips: The role of pharmaceutical eQMS
An electronic Quality Management System (eQMS) can be a valuable tool when implementing and maintaining an effective ICH Q10 Pharmaceutical Quality System.
An effective electronic Quality Management System (eQMS) is essential for modern pharmaceutical operations, ensuring seamless integration of quality processes across the product lifecycle while maintaining stringent regulatory compliance and operational efficiency.
An eQMS can streamline processes, improve data integrity, and facilitate collaboration across different functions and sites. It can also aid in monitoring, reporting, and analyzing quality data, enabling better decision-making and continual improvement.
At Scilife, we believe that having the right tools allows pharma organizations to ensure compliance and quality, with minimum risks, at an affordable price.
Scilife's eQMS simplifies the quality process, providing users with a comprehensive set of features to help manage compliance, track quality, and automate processes. The eQMS is designed to be easy to use and intuitive, allowing users to quickly gain insight into their operations and make informed decisions.
Among its key functions are:
- Compliance: eQMS systems help pharmaceutical companies adhere to regulatory requirements, such as Good Manufacturing Practices (GMP), and ICH Q10 PQS, by providing a centralized platform to manage quality-related documentation, processes, and data.
- Risk Management: eQMS systems enable proactive risk identification, assessment, and mitigation through features like CAPA (Corrective and Preventive Actions) management, deviation reporting, and change control.
- Process Optimization: Automation and integration within an eQMS can improve efficiency, reduce errors, and enhance overall productivity in quality-related activities like audits, training, and supplier management.
- Data Integrity: eQMS solutions ensure the reliability, accuracy, and traceability of quality data by providing secure, controlled, and auditable systems for data management.
- Continuous Improvement: Through real-time monitoring of critical quality metrics, eQMS platforms offer pharmaceutical companies the ability to identify trends, generate reports, and make data-driven decisions to continually improve quality management.
Conclusion
The ICH Q10 guideline provides a comprehensive framework for establishing and maintaining an effective Pharmaceutical Quality System throughout the product lifecycle. By adopting the principles and elements outlined in ICH Q10, pharmaceutical organizations can achieve product realization, maintain a state of control, foster innovation, and ensure consistent product quality.
Implementing the ICH Q10 model requires a systematic approach, organizational commitment, and robust eQMS, for document management, corrective actions, change management, monitoring, and knowledge management.
Implementing the ICH Q10 PQS alongside an eQMS presents three pivotal takeaways for pharmaceutical companies:
The key takeaways are:
- Enhanced compliance and efficiency: ICH Q10 and eQMS integration enables streamlined adherence to regulatory standards throughout the product lifecycle. By centralizing quality processes and documentation, companies achieve robust compliance, minimize risks, and optimize operational efficiency.
- Facilitation of continuous improvement: The combined framework supports a proactive approach to quality management. Through real-time monitoring, integrated QRM tools, and centralized knowledge management, organizations can identify areas for enhancement, drive continual improvement initiatives, and adapt swiftly to industry changes.
- Advancement of pharmaceutical quality assurance and innovation: Leveraging eQMS not only improves operational workflows but also accelerates time-to-market for new products. By optimizing resource allocation and reducing compliance costs, companies can focus on innovation, ensuring the delivery of safe, high-quality medicines that meet patient needs worldwide.
