Pharmaceutical Quality System Guideline as per ICH Q10.
This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model.
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.
ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.
This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological products, throughout the product lifecycle.
The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage.
For the purposes of this guideline, the product lifecycle includes the following technical activities for new and existing products:
– Pharmaceutical Development:
– Drug substance development;
– Formulation development (including container/closure system);
– Manufacture of investigation products;
– Delivery system development (where relevant);
– Manufacturing process development and scale-up;
– Analytical method development.
– Technology Transfer:
– New product transfers during Development through Manufacturing;
– Transfers within or between manufacturing and testing sites for marketed products.
ICH guideline Q10 on pharmaceutical quality system (EMA/CHMP/ICH/214732/2007)
– Commercial Manufacturing:
– Acquisition and control of materials;
– Provision of facilities, utilities, and equipment;
– Production (including packaging and labelling);
– Quality control and assurance;
– Distribution (excluding wholesaler activities).
– Product Discontinuation:
– Retention of documentation;
– Sample retention;
– Continued product assessment and reporting.
Relationship of ICH Q10 to regional GMP requirements, ISO standards and ICH Q7
Regional GMP requirements, the ICH Q7 Guideline, “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities. ICH Q10 provides a harmonised model for a
pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements.
The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., Development). The quality system elements and management responsibilities described in this guideline are intended to encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle.
Relationship of ICH Q10 to regulatory approaches
Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and process understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Potential opportunities to enhance science and risk based regulatory approaches are identified. Regulatory processes will be determined by region.
Pharmaceutical Quality System (ICH Q10)