Woman Analyzing ICH Q10 QMS

ICH Q10 Pharmaceutical Quality System

The ICH Q10 pharmaceutical quality system document is an all-inclusive manuscript that serves as a model for an efficient quality management system (QMS) in the pharmaceutical industry.

By implementing the ICH Q10 pharmaceutical quality system you will demonstrate to both the pharmaceutical industries and the regulatory authorities’ intentions to the world that the qualities of your products are of the highest standards. The guideline is based on quality concepts of the International Standards Organisation (ISO) and Good Manufacturing Practice (GMP) guidelines.

Whilst implementing the ICH Q10 quality management system can be complex, one key challenge that your organization is likely to face is that the guidelines must be applied throughout each of your products’ lifecycles. The QMS should also include the most suitable resources, processes, and responsibilities that are needed to assure the quality of all purchased materials and outsourced activities.

One option that you should consider at the very beginning is to bring in an efficient pharmaceutical eQMS software such as the SimplerQMS software. It helps streamline a wide variety of quality processes and helps you ensure that your organization has the required capabilities for complying with ICH Q10 QMS guidelines.

This article provides the answers to some of the most common questions about implementing the ICH Q10 quality management system and shows how an eQMS can be beneficial to your organization.

Here’s what we will discuss in this article:

What Is the ICH Q10 Quality Management System?

The ICH Q10 pharmaceutical quality system is part of a new ICH tripartite guideline that intends to effectively manage the pharmaceutical quality management system.

ICH Q10 particularly focuses on all the systems that support the lifecycles of all your company’s products – APIs, drug products, biotechnology, and biological products.

Implementation of ICH Q10 QMS will enforce that your organization, as well as the regulatory authorities of the country where you market your products, have the best interests of the end-users.

By executing ICH Q10 guidelines, your organization is facilitating both innovation and constant improvement of your products.

ICH Q10 applies to all companies that manufacture pharmaceutical drug substances and drug products. So, if you are manufacturing one or more of these products – acetaminophen (an API), COVID-19 vaccine (a drug product), lactose-free milk (a biotechnology product), or recombinant therapeutic proteins (a biological product).

ICH Q10 is part of a tripartite guideline that includes ICH Q8 and ICH Q9.

ICH Q8, Q9, and Q10 deal with different aspects of product development and manufacturing in the pharmaceutical industry:

The foundation of ICH Q10 is built on regional GMP requirements. In fact, ICH Q10 enhances GMPs as it describes specific quality system elements and responsibilities of the management.

An efficient eQMS for pharmaceutical organizations such as SimplerQMS will provide your organization with integrated quality management system software that helps you ensure compliance with the GMP requirements and guidelines of ICH Q10.

Recommended Reading

Why Is ICH Q10 Quality Management System Important?

Throughout the lifecycle of a pharmaceutical product, ICH Q10 will guide your organization to innovate and continually improve the QMS.

The most important aspects that the ICH Q10 pharmaceutical quality system guidelines deal with are:

  • A state of continual improvement that enhances the ability of all the systems and processes to meet applicable quality standards.
  • Ability to deliver quality products that benefit the end-users.
  • Proficient monitoring and control systems that augment the performance of all systems and processes.

ICH Q10 Pharmaceutical Quality System Model

For the pharmaceutical organization, effective QMS is made possible by the implementation of the ICH Q10 QMS model which is detailed in the diagram below.

ICH Q10 Quality Management System Model Diagram

The various elements are described in greater detail in the following sections.

ICH Q10 Lifecycle Stage Goals

According to the ICH Q10 pharmaceutical quality system guidelines, the lifecycle of both existing and new products that your organization manufactures must include the following 4 technical activities:

  • Pharmaceutical development
  • Technology transfer
  • Commercial manufacturing
  • Product discontinuation
ICH Q10 Lifecycle Stage Goals

Pharmaceutical Development

In the pharmaceutical development phase, the goal is to design products and plan the steps in manufacturing. Your organization will focus on meeting the needs of patients, caretakers, and healthcare professionals and comply with the guidelines of regulatory agencies.

The technical activities conducted in this phase are:

  • Developing drug substances
  • Developing formulations, that include both container and closure systems
  • Developing analytic methods
  • Developing manufacturing processes and plans for the scale-up
  • Manufacture of investigational products

An efficient eQMS such as SimplerQMS, which is made for life science industries, including pharmaceuticals, is advantageous for your organization.

QMS software solution by SimplerQMS offers tools to help you develop safe, effective pharmaceutical products, quickly while ensuring compliance with regulatory requirements.

Technology Transfer

In the technology transfer phase, the goal is to transfer knowledge about both processes and products from the development phase to the manufacturing phase.

The technical activities associated with this phase are:

  • Transfer of products from development to manufacturing
  • For marketed products, transfer between manufacturing and testing sites

With the help of SimplerQMS, you will avoid all paper trails and access unmatched quality process coverage. You will be able to easily track your documents between departments and between facilities.

Commercial Manufacturing

The goal of the commercial manufacturing phase of the ICH Q10 pharmaceutical quality system is to help your organization manufacture products through a process of continuous improvement and a state of control.

In this phase, the technical activities that your organization will perform are:

  • Acquire and control materials
  • Provide for facilities, equipment, and utilities
  • Fabricate packaging materials and labels
  • Store, release, or distribute the manufactured products

The enhanced features of SimplerQMS will help you automate workflows such as distribution of work instructions, report generation, escalation of overdue activities, and more. This will help you streamline manufacturing production processes and reduce downtime, as a result, escalate drug product release to the market.

Product Discontinuation

In this phase, your organization will supervise the end of a product’s lifecycle.

The technical activities associated with this phase are:

  • Management of document retention and sample retention
  • Performing continuous product evaluation and reporting

The SimplerQMS software helps your organization to track all your QMS documentation, processes, protocols, and products so that you can ensure compliance with regulatory requirements such as ICH Q10, GxP, EU Annes 11, FDA 21 CFR Part 11, and others.

Management Responsibilities

When the management of your organization is committed to quality and a competent pharmaceutical QMS, the entire organization will follow.

Let us now understand the ways and means by which the management can effectively achieve the objectives of the pharmaceutical QMS.

ICH Q10 Management Responsibilities


  • As a member of management, you will involve yourself in the design, execution, monitoring, and continuation of the pharmaceutical quality management system.
  • You will ensure that there is an effective and judicious communication and escalation process where issues pertaining to quality can be raised with the appropriate management heads.
  • You will assign sufficient resources, practice continual improvement, and conduct regular management reviews of the pharmaceutical QMS.

Quality Policy and Planning

  • As senior management, you will ensure that the required quality objectives are defined clearly and communicated to the entire organization.
  • These quality objectives need to align with your company’s strategies.
  • Periodic reviews of the quality policy are crucial to maintaining effectiveness.
  • You will bring in performance indicators to measure the progress made with regard to the quality objectives.

Resource Management

  • You will determine the appropriate resources needed in terms of humans, materials, equipment, finances, and facilities, for implementing and maintaining the pharmaceutical QMS.

Internal Communication

  • You will ensure the establishment of a proper in-house communication process that will allow the flow of relevant information between the different departments and management levels in your organization.

Change in Product Ownership

  • When a product changes ownership, say via acquisitions, you will ensure that all relevant information is also transferred and that the current responsibilities are identified for all the companies involved.

Pharmaceutical Quality Management System Elements

Four key elements of the pharmaceutical quality management system are outlined below.

The same may be required, to a certain extent, for your regional GMP regulations.

But the ICH Q10 guidelines go beyond these and enhance the elements in such a manner as to promote product quality throughout its lifecycle.

These elements are the following:

  • Process Performance and Product Quality Monitoring System
  • Corrective and Preventive Action (CAPA) System
  • Change Management System
  • Management Review of Process Performance and Product Quality
ICH Q10 PQS Elements

Process Performance & Product Quality Monitoring System

Your organization will need to plan and successfully execute a monitoring system for process performance and product quality.

“The expected result – maintenance of a state of control.”

By providing an effective monitoring system, you will assure your end-users and the regulatory agencies that your company’s products are of the desired quality.

Also, you will identify areas that need continual improvement.

When you use QMS software such as SimplerQMS with a built-in issue management module, you will be able to automatically collect data, route documents, escalate overdue activities, streamline compliant issue and deviation management activities, and much more.

This helps you ensure that the performance and safety monitoring of your pharmaceutical products and related processes is much easier and more efficient.

Recommended Reading: Guide to Deviation Management Process

Corrective / Preventive Action (CAPA) System

It is imperative that your organization has a system in place for the implementation of corrective actions and preventive actions (CAPAs) when you investigate complaints, non-conformances, product rejections, recalls, deviations, audits, etc.

With the use of a CAPA management solution such as SimplerQMS software, you can readily streamline the entire CAPA process by automating various activities. With this software, you can automate tasks related to CAPA, such as data collection, routing, notifications, follow-ups, approvals, escalations, and others.

The software ensures that the right people are notified about the assigned tasks, at the right time. This helps you ensure that they never miss an assignment again.

Recommended Reading: What is CAPA in the Pharmaceutical Industry?

Change Management System

With a focus on evaluating, approving, and executing changes in innovation, continual improvement, CAPA systems, monitoring of product quality, and process performance, your organization must put in place a highly effective change management system.

The changes that you propose must be evaluated by personnel with the required expertise and knowledge. When bringing in these changes, you must also be cognizant of market authorization.

With SimplerQMS change control management solution the change management process becomes a lot easier.

You will manage, see, and understand every change in a completely traceable, centralized system.

Using SimplerQMS, you will be able to automatically track all changes, including those to SOPs, instructions, products, and product processes. Send changes through the approval process with ease, and ensure that the implementations have taken place.

Recommended Reading: Change Control in Pharma: Best Practices & Examples

Management Review of Process Performance and Product Quality

Management review in your organization will guarantee that product quality and process performance is managed over the lifecycle of every product.

You will typically include the results of inspections from regulatory agencies, audits, assessments, and commitments made to them in your management review. You will need to identify necessary actions, including knowledge dissemination, enhancement of the manufacturing processes and products, and providing resources.

SimplerQMS provides you with real-time dashboards and KPI reports that are most timely and beneficial during your management review meetings. With these, you can assess product quality and various quality process performance throughout the lifecycle of a given product.

Knowledge Management and Quality Risk Management

With the use of knowledge management and quality risk management, your company will be able to successfully and effectively implement the ICH Q10 quality management system.

ICH Q10 QMS Enablers

What is Knowledge Management?

Knowledge management is a methodical approach to the acquisition, analysis, storage, and dissemination of all information that is relevant to your company’s products, components, and manufacturing processes.

The sources for this knowledge can be but are not limited to, pharmaceutical development studies, prior knowledge (either from the public domain or from internal sources), technology transfer activities, product validation studies, and your organization’s manufacturing experience.

As you may have guessed, SimplerQMS can also be used to streamline the knowledge management within your organization. With our document control software solution, any type of file can be stored in a secure cloud-based storage location for access only by authorized users.

What is Quality Risk Management?

Quality risk management is an essential part of your organization’s pharmaceutical QMS.

With its help, you can proactively identify, evaluate scientifically, and control potential risks to quality.

By using our risk management module, you can consolidate risk by keeping your risk management documentation interlinked with other quality processes across your organization, well-organized, and up to date in one common and traceable system.

The Role of Pharmaceutical QMS Software

You can implement the ICH Q10 quality system model in one of two ways – manual or digital.

Traditionally, companies used to use a manual paper-based QMS system.

A manual paper-based QMS system has its own limitations and drawbacks such as the need for storage space for a ton of documents. Next, these documents can get lost, damaged, or mishandled leading to security problems.

And how do you transport these documents within and outside the organization?

When you have to make changes to a paper-based document, you obviously need the document rewritten and multiple copies made.

All these lead to increased expenses for your organization.

Looking at these problems, many organizations are transitioning toward a digital quality management system that helps the organization in enhancing efficiency, reducing human error, and ensuring compliance with regulatory compliance.

The SimplerQMS software solution provides a robust cloud-based QMS software solution that helps your organization manage quality and compliance with the complex regulations and standards mandated for the life sciences industry, including ICH Q10 quality management guidelines.

Pharmaceutical eQMS software by SimplerQMS provides unmatched process coverage which allows you to interconnect to all your quality processes, and store data in a single, pre-validated, cloud-based platform.

From document management, with the FDA 21 CFR Part 11 compliant electronic signatures and time-stamped audit trails, to CAPAs or any other quality event, with automated assigning of assignments and notifications, SimplerQMS helps you work more efficiently and maintain compliance with the ICH Q10 quality system guidelines and other regulatory requirements applicable to pharmaceutical organizations.

Final Thoughts

ICH Q10 pharmaceutical quality system guidelines are a model for the effective quality management system for organizations in the pharmaceutical industry. These guidelines are based on ISO quality concepts and incorporate regional GMP regulations. Along with ICH Q8 and ICH Q9, ICH Q10 forms a tripartite guideline that all pharmaceutical companies need to implement to show their end-users and regulatory agencies that their products are safe and efficacious.

It is difficult for organizations to continue to use manual paper-based QMS systems because of the many inherent flaws and drawbacks.

When you decide to invest in the SimplerQMS software solution, you will be able to streamline your entire QMS workflow and ensure compliance with ICH Q10 quality system requirements.

To learn more about our QMS software solution we recommend you book a personalized demo today and see for yourself how you can benefit from SimplerQMS.

eQMS Business Case Template

Illustration of eQMS Business Case Template