Aug 29, 2019 Robert Fenton

ICH Q10 Pharmaceutical Quality System: The Role of an eQMS

The 2008 version of the ICH Q10 Pharmaceutical Quality System (PQS) was designed to improve public health around the world by helping enhance the quality and availability of medicine. ICH Q10 is built to help you and your team deliver high-quality products quickly to the people that need them most.

But, how do you decipher the sea of confusing acronyms and actually implement ICH Q10 in your company? How will you and your team put the standards into practice?

Many industry-leading companies rely on quality management system software built specifically for the pharmaceutical industry. At Qualio, our eQMS (enterprise Quality Management System) is built to help startup and scale-up life sciences companies achieve compliance and improve product quality.

As you put the ICH Q10 in place in your business, you can rely on software like Qualio to help you track your processes from end-to-end throughout all of the product lifecycles identified.

ICH Q10 Pharmaceutical Quality System Implementation in Product Lifecycles

What is the ICH Q10 Pharmaceutical Quality System?

The ICH Q10 guideline is applicable to companies that manufacture pharmaceutical drug substances and drug products — including biotech and biological products. ICH Q10 is a single comprehensive standards model that outlines the structure and guidelines necessary to build an effective pharmaceutical quality system to support pharmaceutical development and manufacturing across the product lifecycle.

The guidelines are based on ISO (International Standards Organization) quality concepts and GMP (Good Manufacturing Practice) regulations. ICH Q10 is one part of a three-part guideline alongside ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management.”

ALSO SEE: What Is cGMP in The Pharmaceutical Industry? An Expert Roundup

ICH Q10 is designed to be implemented through different stages of a product lifecycle. It is not intended to create new expectations beyond the ones currently required by regulators — which is why the pieces that are added to the GMP requirements are deemed optional.

ICH Q10 addresses the following four phases of the product lifecycle to help control quality and assure the development of safe pharmaceutical products.

1. Pharmaceutical Development

The goal of activities in the pharmaceutical development phase is to design a product and plan the manufacturing process. The process should be able to deliver the necessary performance, meet the needs of patients and healthcare professionals, and comply with regulatory guidelines.

Technical Activities in the Pharmaceutical Development Stage

  • The development of drug substances
  • The development of formulations, including container and closure systems
  • Manufacturing investigational products
  • The development of a delivery system when relevant
  • The development of the manufacturing process and planning the scale-up
  • The development of an analytical method

How Does an eQMS Help?

An eQMS system like Qualio helps you bring your products to market quickly with design control and risk management features. We integrate directly with your pre-production and post-production quality activities. You can capture drug development outputs and collate them together for a seamless review and submission at each step.

2. Technology Transfer

Activities related to technology transfer are intended to transfer process and product knowledge between manufacturing and development. This knowledge is the foundation for the manufacturing process, process validation approach, control strategy, and ongoing continual improvement.

Technical Activities in the Technology Transfer Stage

  • Transferring products from development to manufacturing
  • Transferring products within or between the manufacturing process and the testing sites for the marketed products

How Does an eQMS Help?

Any time any product needs to move from one department or facility to another one, there needs to be a paper trail. Your document management process needs to be defined and your documents need to be tracked. Qualio makes this easy.

RELATED READING: The Key to Future-Proofing Pharma Compliance

3. Commercial Manufacturing

Manufacturing activities are designed to achieve product realization by establishing and maintaining a state of control and enabling continual improvement. The PQS should ensure that the product quality is met, suitable process performance is achieved, the controls are appropriate, improvement opportunities and identified and evaluated, and knowledge is continually expanded.

Technical Activities in the Commercial Manufacturing Stage

  • Materials are acquired and controlled
  • Facilities, equipment, and utilities are provisioned
  • Products, packaging, and labels are produced
  • Quality control and assurance are performed
  • Products are released, stored, or distributed — including wholesale items

How Does an eQMS Help?

Qualio helps automate your quality processes with guided and easy-to-follow workflows. You can easily monitor a variety of activities and close the loop for end-to-end traceability.

4. Product Discontinuation

Product discontinuation activities are designed to manage the end of the product lifecycle. An approach is planned ahead and used to manage activities related to document retention, sample retention, and provide continual product assessment.

Technical Activities in the Product Discontinuation Stage

  • Document retention is managed
  • Sample retention is managed
  • Continuous product assessment and reporting is performed

How Does an eQMS Help?

Qualio helps you track your documents and products to reduce your risk of failing regulatory compliance. We organize all of your information so that you can easily find the history of each product and sample that you manage. Your reporting dashboards make information easily accessible in a way that pen and paper quality systems can’t.

How to Choose the Right eQMS for Your Company

Every company is different, and every eQMS software is designed with certain goals and needs in mind. Finding the right eQMS for your company starts with understanding your needs.

  • What gaps do you have in your current processes and systems?
  • How are those gaps affecting you — time, resources, quality?
  • Which compliance regulations are you required or trying to meet?

After you have a firm idea of what you need and what you want out of your eQMS software, you can start looking at different options and considering what’s going to work for you.

Start by requesting a free demo of Qualio. We will walk you through a custom demo that will show you exactly what you can achieve by leveraging our software and a quality-driven approach. New call-to-action


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Published by Robert Fenton August 29, 2019