The pharmaceutical industry's efforts to implement modern quality systems took a step forward with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issuing its draft guidance, ICH Q10 Pharmaceutical Quality System. The guideline describes the modern quality systems necessary to facilitate continual improvement over the life cycle of a medicinal product. The guideline is intended to augment existing good manufacturing practice (GMP) requirements in the ICH participating regions (the United States, Europe, and Japan) to create modern and robust quality systems.
Origins of ICH Q10
The genesis of ICH Q10 dates back to 2003 when ICH set the ICH Quality Vision. The guidelines, ICH Q8 Pharmaceutical Development (1), ICH Q9 Quality Risk Management (2), and ICH Q10 (3), are cornerstones of the ICH Quality Vision for creating a regulatory framework that is based on a harmonized pharmaceutical quality system, applicable across the life cycle of the product, which emphasizes an integrated approach to quality risk management and science.
"It was decided to go to ICH Q10 to bring the ICH vision to fruition over the product life cycle," explains Joseph Famulare, deputy director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER). "The result is that firms that employ quality by design and use risk-management principles (ICH Q8 and ICH Q9) can use a robust quality system to manage change and continual improvement and this would lessen the need for post-approval filings, putting quality more in the hands of the manufacturer," he says.
ILLUSTRATION: MELISSA MCEVOY, PHOTOGRAPHY: JIM SHIVE MAP: PHOTOS.COM
Objectives of ICH Q10
The pharmaceutical quality system encompassed in ICH Q10 seeks to realize several crucial goals (4):
- Achieve product realization. The manufacturer seeks to consistently provide a product of the quality necessary to meet the requirements of patients, healthcare professionals, regulatory authorities, and internal customers.
- Establish and maintain a state of control. This goal is met by using effective monitoring systems for process performance and product quality to provide assurance of continued suitability and capability of process.
- Facilitate continual improvement by identifying and implementing necessary product-quality improvements, process improvements, variability reduction, innovations, and enhancements of the pharmaceutical quality system, thereby increasing the ability to consistently fulfill quality requirements. Risk management techniques may be used to identify necessary areas for improvement.
The foundation for ICH Q10
The proposed ICH Q10 describes a pharmaceutical quality system that is based on concepts from the International Organization on Standardization and GMP regulations (3). Regional GMP requirements and ICH Q7 Good Manufacturing Practice Guide for Active Ingredients form the foundation of ICH Q10 (3). The pharmaceutical quality system under the proposed ICH Q10 emphasizes four specific elements:
- Change-management system
- Process performance and product- quality monitoring system
- Corrective and preventive action (CAPA) system
- Management review of process and performance quality.
The guideline, which is optional, applies to drug substances and drug products, including biotechnology and biological products, throughout the product life cycle (3). This framework is outlined in Figure 1.
Figure 1: The framework, components, and application of a pharmaceutical quality system. (FDA AND GEORGES FRANCE, EFPIA)