Pharmaceutical Quality System
A quality system is critical for firms operating in regulated environments where compliance with good practices—Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP)—is required. The pharmaceutical quality system is a framework for ensuring that quality is designed and built into each step of the drug manufacturing and production process. It delineates a set of responsibilities, processes, and procedures that pharmaceutical companies should use to maintain the purity, consistency, and quality of their products.
Implementation of a robust pharmaceutical quality system is one way that drug manufacturers can demonstrate their commitment to quality and assure their pharmaceutical supply partners and patients that their products are manufactured to have the desired quality and performance attributes. It helps pharmaceutical companies ensure that their drugs are safe, deliver the intended performance, and consistently meet the needs of customers.
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Defining the pharmaceutical quality system
According to the U.S. Food and Drug Administration (FDA), an effective pharmaceutical quality system should help firms ensure compliance with Current Good Manufacturing Practices (CGMPs), and it is the key system evaluated by the FDA during inspections. It is a quality management system that provides pharmaceutical companies with an integrated framework, or an organizational structure, processes, and procedures, for implementing quality assurance, risk management, and continuous improvement in drug manufacturing. It is a set of guidelines, standards, and regulations that firms use to ensure that their medications are safe, stable, and perform as described on the label and over the course of each product's shelf life.
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Building an effective pharmaceutical quality system
In its ICH Q10 guidelines, the Implementation Working Group of the ICH, or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, describes a comprehensive model for an effective pharmaceutical quality system. It is based on ISO quality concepts, augments existing GMPs for the pharmaceutical industry, and has come to be integrated in regional GMP requirements in both the US and the EU. It is intended to encourage the use of science and taking a risk-based approach in promoting continual improvement across the lifecycle of each drug product—from development and technological transfer to commercial manufacturing, which includes pharmaceutical quality control and assurance processes, and up to and including product discontinuation.
The main elements of the pharmaceutical quality system, as described in the ICH Q10 guidelines, are a Process Performance and Product Quality Monitoring System, a Corrective Action and Preventive Action (CAPA) System, a Change Management System, and the Management Review of Process Performance and Product Quality. These four elements are used together to monitor, control, and continuously improve manufacturing process performance and product quality at each stage of the product lifecycle. By implementing an effective pharmaceutical quality system, firms can not only enhance the quality and availability of medicines in the interest of public health but also promote innovation and align drug development and drug manufacturing activities.
Key advantages of the pharmaceutical quality system
In addition to driving improvement in process performance and product quality, firms with robust pharmaceutical quality systems are more likely to meet the requirements of CGMPs and realize the advantages of minimized downtime, improved adaptability to changing conditions, and cost reductions resulting from fewer investigations, less internal failures (rejects, reworks, reprocessing), and reduced product loss.
Effective use of the pharmaceutical quality system helps organizations create a quality culture in which leaders are committed to prioritizing quality, each person in the organization understands their role in and responsibilities for ensuring quality, and any and all changes made to the drug product or its manufacturing processes are evaluated in terms of their contribution to optimizing process performance and enhancing product quality. A robust pharmaceutical quality system fosters excellence and accountability in quality management and quality review, drug development and production, and drug supply management.
Key enablers of the pharmaceutical quality system
The two key enablers of an effective pharmaceutical quality system are knowledge management and quality risk management. Knowledge management necessitates that companies take a systematic approach to acquiring, analyzing, managing, and sharing information related to their products, product components, and manufacturing processes. A robust pharmaceutical quality system requires that companies properly store and manage process and product knowledge—from development through the commercial life of the product and up to its removal from their portfolio of finished products. Quality risk management facilitates the continual improvement of process performance and product quality by pushing firms to take a proactive approach to identifying, assessing, and mitigating potential risks to product quality.
Technologies enabling an effective and holistic pharmaceutical quality system
Forward-thinking pharmaceutical firms are using technology to streamline quality management processes, drive compliance, and achieve consistency in implementing the directives of their pharmaceutical quality system across sites and suppliers. Technology such as the digital supply network and multienterprise work management software help companies assure proper knowledge management and promote thorough quality risk management.
Through the use of a cloud-based digital network platform, which facilitates seamless communication and real-time information sharing across functions, systems, and organizations, they can extend their quality system to their upstream and/or downstream partners in the pharma value chain. By carrying out supplier management more effectively and efficiently, they can better mitigate supplier risk and maintain product quality across the supply chain. A digital network platform provides members with the ability to create digital supply networks on demand and achieve the end-to-end supply chain visibility they need to ensure success.
Pharmaceutical Quality System FAQs
What is a pharmaceutical quality system?
The pharmaceutical quality system is a set of guidelines delineating specific responsibilities, processes, and procedures that should be taken or carried out by a pharmaceutical manufacturer in order to ensure the safety, efficacy, and intended performance—purity, stability, and potency—of its products.
What are the benefits of implementing an effective pharmaceutical quality system?
With an effective quality system in place, pharmaceutical manufacturers can better understand and continuously improve process performance and product quality trends, reduce costs associated with and product loss resulting from internal failures such as rejects, reworks, and reprocessing, and boost customer satisfaction and loyalty.
What is ICH Q10?
ICH Q10 is a set of guidelines that is provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and describes the "Pharmaceutical Quality System". It provides a comprehensive model of a quality management system suited to the needs of the pharmaceutical industry and offers drug manufacturers a systematic means of ensuring that they consistently produce and deliver to market high-quality products.