ICH Q10 Pharmaceutical Quality System

Author: Ian Lucas, Director , SeerPharma, Melbourne

April 2012

ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout different stages of a product lifecycle.

ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout different stages of a product lifecycle. This paper focuses on the commercial manufacturing stage and describes the key aspects from ICH Q10 and offers an automated solution to assist with compliance. For more details on the development stage, refer to the paper entitled Automating Compliance with ICH Q8. It should be noted that ICH Q10 is not intended to create any new expectations beyond current regulatory requirements, so adherence to its principles should be achievable by all pharmaceutical companies. The key objectives are to:

Achieve product realization (assumed already achieved for this paper) Establish and maintain a state of quality control Facilitate continual improvement
To achieve this the key is to gather, retain, analyze and disseminate product and process knowledge (Knowledge Management) and effectively utilize risk management technique to concentrate efforts on the appropriate areas. This needs to be coupled with strong management commitment to implement integrated systems of quality control and the resources to maintain and improve this.

Structuring the Quality Management System

Quality management systems must be well structured to match the size, complexity, culture and aims of each business. The quality message must be well understood and followed by everyone within the company. Quality must start from a solid foundation of raw materials and components, so any outsourced materials and activities must also comply with the companys quality philosophy. Having a Quality Manual that describes the quality systems is vital for consistency in scope, operation and responsibility. This is not something that can be just bought off the shelf and implemented. It needs to be discussed, refined and constantly reviewed. Sometimes, elements need to be explicitly defined and other times elements need to be presented as guidance that can be modified based on reasoning and justification. Management need to commit serious time and effort in developing these systems in consultation with the key stakeholders of each system and ensuring that these systems remain effective.

Automating the Process

Although automating the systems is not necessary in all cases, as more systems are developed and introduced, and more data is obtained and required, having automated systems that enforce processes where required and provide recording capabilities where required, can greatly raise the probability that the quality system will continue to operate effectively. The focus however, should not be on the automation, but on the processes themselves.

The Pharmaceutical Quality System Elements

The ICH Q10 model describes four elements that require review and action to promote the lifecycle approach to product quality. These 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

Process Performance and Product Quality Monitoring System

A state of control cannot be demonstrated unless key quality processes are defined, monitored, reviewed and refined. Processes and parameters to monitor should be defined by key personnel, historical and current data, informed assumptions and appropriate risk management techniques. (ICH Q9 gives guidance on several common risk management techniques.) These parameters, together with subsequent actions, define the Control Strategy. Output from this monitoring can feed into the CAPA system and possibly change management. This monitoring is not limited to internal sources only, so systems such as complaints, product rejections, non-conformances, recalls, deviations, audits and regulatory inspections should also be included.

Corrective Action and Preventive Action (CAPA) System

People often use CAPA as a catch all for all quality events and investigations. Processes for complaints, product rejections, non-conformances, recalls, deviations, out of specifications, audits, regulatory investigations and monitoring trends should exist but these should only feed into a true CAPA system should they require a full root cause analysis and a review on effectiveness. Each one of these quality processes needs to be defined via workflows and ownership/ responsibility matrices for as many business scenarios as can be documented. (As more scenarios are discovered, the processes evolve and are refined). Consideration needs to be given to the interaction of the different processes and the consistency of approach across the different systems. This is part of the management review mentioned below.

Change Management System

Although CAPA can be considered the heart of a quality management system, all key processes (e.g. validation) cannot be effective without an effective change management system. Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. Companies often have several change processes depending upon the areas involved, the item under change and the stage of the product lifecycle. Management must ensure that these change processes are fully inclusive of all situations and that the differences are understood and implemented by everyone within the organization. As with CAPA, changes should be evaluated by appropriate expert teams to ensure the change is justified, and evaluated after implementation to confirm the change objectives were achieved and no inadvertent negative impact on product quality was introduced.

Management Review of Process Performance and Product Quality

Management, in the strictest sense, is responsible for providing resources and managing resources. Management exists at all levels of the business so this resource management extends to resources at all levels. To ensure resources are effectively managed they must be constantly reviewed. ICH Q10 defines this management review as a series of reviews at various levels of management that should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review. That is, findings need to be communicated upwards and downwards. Actions from the reviews should facilitate:

Improvements Provision, training and/or realignment of resources Capture and dissemination of knowledge.

Making it all happen with an Automated Solution

As mentioned earlier, automation alone will not achieve compliance or guarantee a workable quality management system. A solution must be tailored based on specific company and system requirements. Therefore to be successful, an automated solution must be developed using a highly configurable toolset that can be upgraded and modified as business and regulatory requirements change.

For many years SeerPharma has worked with pharmaceutical companies to tailor quality systems to meet their quality system needs. SeerPharma has also chosen EtQ Reliance as the most highly configurable automated quality management toolset to implement for their customers.

EtQ Reliance provides all the base quality modules required to comply with the ICH Q10 model for a pharmaceutical quality system.

SeerPharma has called their tailored automated solution iQA Integrated Quality Assurance. This provides both a powerful workflow engine with a proven methodology for success.

Satisf ying ICH Q10

ICH Q10 defines the two key enablers as Knowledge Management and Quality Risk Management. As defined, Knowledge Management is a systematic approach to acquiring, analyzing, storing and disseminating information related to products, manufacturing processes and components. SeerPharma works with customers to define this approach through formal User Requirements and Design specifications and converts these into integrated business workflows and forms.

Business rules enforce the gathering of data by the correct individuals or groups and the timely processing through the workflow. Automatic email notifications and escalations to management ensure information is correctly disseminated as required.

Risk Management
EtQ Reliance provides tools for FMEA (Failure Modes and Effects Analysis), HACCP (Hazards Analysis and Critical Control Points), JSA (Job Safety Analysis) and configurable risk matrices. All these tools can be configured to interface directly with the other quality modules to comply with the principles of ICH Q9 and Q10. As the solution also provides a document management system (or can be interfaced with an existing document management system) and training module, the Quality Manual (and training on this) can be included in the solution.

Quality Monitoring and Review

Charts and views can be easily created to show all data in many formats.

As more knowledge is learnt about the process, quality alerts can be configured that automatically notify individuals (or perform activities) based on recorded criteria (eg more than 3 high risk CAPAs in any month).

Conclusion
In conclusion, ICH Q10 describes a science based model to facilitate innovation and continual improvement with product and process development, transfer, manufacturing and discontinuation. An iQA solution (with SeerPharma knowledge and experience and the EtQ Reliance toolset) provides an excellent platform to automate the many quality systems required to achieve the ICH Q10 model. For more information on automated compliance solutions or to discuss you specific requirements, please contact SeerPharma.

About the author:

Ian Lucas, Director SeerPharma
Ian has over 20 years experience in the pharmaceutical industry developing and implementing software solutions. He has designed and developed company wide MES (Manufacturing Execution Systems) and batch document management systems. As manager of the iQA (integrated Quality Assurance) software business unit he gets involved with project management and technical development of dealing with third party software companies and delivery to clients. Ian also provides Computer Validation consulting advice, and develops and delivers computer validation training courses. He has been a regular presenter at international conferences on practical approaches to computer validation.

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