Thursday, 25 April 2013


The European Medicines Agency divides the ICH harmonised tripartite guideline in five main paragraphs: 
  1. Pharmaceutical Quality System
  2. Management Responsibility
  3. Continual improvement of process performance and product quality
  4. Continual improvement of the pharmaceutical quality system
  5. Glossary

ICH Q10 describes a 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. 

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. 

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 investigational products 
    • Delivery system development (where relevant) 
    • Manufacturing process development and scale-up 
    • Analytical method development.Pharmaceutical Quality System (ICH Q10) 
    • EMA/INS/GMP/79818/2011 Page 4/18 
  • Technology transfer 
    • New product transfers during development through manufacturing 
    • Transfers within or between manufacturing and testing sites for marketed products 
  • Commercial manufacturing 
    • Acquisition and control of materials 
    • Provision of facilities, utilities, and equipment 
    • Production (including packaging and labelling) 
    • Quality control and assurance 
    • Release 
    • Storage 
    • Distribution (excluding wholesaler activities) 
  • Product discontinuation 
    • Retention of documentation 
    • Sample retention 
    • Continued product assessment and reporting 

To meet the objectives, ICH Q10 augments GMP 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. 

Implementation of the Q10 model should result in achievement of three main objectives which complement or enhance regional GMP requirements: 
  • Achieve product realisation 
  • Establish and maintain a state of control 
  • Facilitate continual improvement 

Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully. 

Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. 

The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: 
  • Process performance and product quality monitoring system 
  • Corrective action and preventive action (CAPA) system 
  • Change management system 
  • Management review of process performance and product quality 

These elements 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. Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative approaches to improve product quality. Each element is followed by a table of example applications of the element to the stages of the pharmaceutical lifecycle.

This diagram illustrates the major features of the ICH Q10 Pharmaceutical Quality System (PQS) model. The PQS covers the entire lifecycle of a product including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation as illustrated by the upper portion of the diagram. The PQS augments regional GMPs as illustrated in the diagram. The diagram also illustrates that regional GMPs apply to the manufacture of investigational products.

The next horizontal bar illustrates the importance of management responsibilities. The following horizontal bar lists the PQS elements which serve as the major pillars under the PQS model. These elements should be applied appropriately and proportionally to each lifecycle stage recognising opportunities to identify areas for continual improvement.

The bottom set of horizontal bars illustrates the enablers: knowledge management and quality risk management, which are applicable throughout the lifecycle stages. These enablers support the PQS goals of achieving product realisation, establishing and maintaining a state of control, and facilitating continual improvement. 

Key Factors

The ICH Q10 document was produced by a team which borrowed from other international quality management standards and concepts that existed in other sectors, most notably the ISO Quality Management System’s ISO 9001 series. The GMPs are a legal requirement, but now form a part of ICH Q10 requirements as well. 

Q10 adds the critical component of management responsibility, for both in-sourced and outsourced activities. It also introduces the lifecycle approach concept where the PQS is applied throughout the product lifecycle. It builds in the concepts of integrating quality risk management (Q9) and knowledge management throughout, to enable the PQS processes. Q10 drives continual improvements of products and processes, as well as the PQS itself. 

These key concepts go way beyond the previous GMPs and the way the GMPs were interpreted. Just following the GMPs and passing occasional regulatory inspections will now become an even more dangerous strategy, as GMPs alone have never driven continued improvement of products, processes and the PQS itself in the way ICH Q10 intends to. 

ICH Q10 is not just the latest fad; it represents a cultural change to the way the pharma sector needs to operate to move toward a better state. 
Cultural changes do not happen overnight. Training and education programs for quality professionals (not just quality unit staff) need to evolve to explain the “WHY,” not just the “HOW.”

To achieve success, both industry and regulators need to continue to open their minds to affect this positive change. Compliance should be simply a deliverable from the PQS, not a separate industry. 

Pharma needs to be less inward looking and stop thinking in terms of: 
  • “We are the pharma sector; this does not apply to us.”
  • “The regulators would never let this happen.”

Individuals with competencies from other areas are needed: 
  • Statisticians 
  • Operational Excellence (OPEX) experts 
  • Quality professionals 

Companies should not embark on LEAN quality management initiatives until first understanding their processes. The evolution continues: 
  • 1970s – 80s: QC mentality 
  • 1980s – 2000s: QA mentality 
  • 2000s – 2020?: PQS mentality 
  • 2020?: Operation excellence is part of quality mentality? 

Together we can implement these quality management systems, to reduce risk, improve regulatory relationships and to create higher quality pharmaceuticals that protect and improve human health. 

Sources: EMA, FDA, Contract Pharma.

1 comment:

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