The Pharmaceutical Quality System For Excipients


The pharmaceutical quality system is a set of guidelines delineating specific responsibilities, processes, and procedures that a pharmaceutical manufacturer should take or carry out to ensure its products' safety, efficacy, and intended performance—purity, stability, and potency.

ICH Q10 is a set of guidelines 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. It offers drug manufacturers a systematic means of consistently producing and delivering high-quality products to market.

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 ensures that quality is designed and built into each step of the drug manufacturing and production process, including excipients. It delineates responsibilities, processes, and procedures that pharmaceutical companies should use to maintain their products' purity, consistency, and quality.

Implementation of a robust pharmaceutical quality system is one way that drug/excipient 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 their drugs are safe, deliver the intended performance, and consistently meet customers' needs.


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 crucial system evaluated by the FDA during inspections. It is a quality management system that provides pharmaceutical companies, including excipient manufacturers, with an integrated framework or an organisational 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.

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 become integrated into regional GMP requirements in the U.S. and the E.U. It is intended to encourage the use of science and take 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 improve the quality and availability of medicines in the interest of public health, promote innovation, and align drug development and drug manufacturing activities.

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 realise the advantages of minimised 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 organisations create a quality culture in which leaders are committed to prioritising quality, each person in the organisation understands their role and responsibilities for ensuring quality, and any changes made to the drug product or its manufacturing processes are evaluated in terms of their contribution to optimising process performance and enhancing product quality. A robust pharmaceutical quality system fosters excellence and accountability in quality management, quality review, drug development and production, and drug supply management.


The two key enablers of an effective pharmaceutical quality system are knowledge management and quality risk management. Knowledge management necessitates companies systematically acquiring, analysing, managing, and sharing information related to their products, product components, and manufacturing processes. A robust pharmaceutical quality system requires companies to properly store and manage process and product knowledge—from development through the product's commercial life 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.

With an effective quality system, pharmaceutical manufacturers can better understand and continuously improve process performance and product quality trends, reduce costs associated with product loss resulting from internal failures such as rejects, reworks, and reprocessing, and boost customer satisfaction and loyalty.

At Clyzo, we ensure the products available for distribution are manufactured under a robust Quality system complying with International/ National Regulatory Requirements.