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Quality Management

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Quality, in the decisions we make and the medicines we produce, is the foundation for executing our vision, purpose and values.

At Takeda, the Global Quality organization covers all end-to-end aspects of the Takeda business, from R&D through Manufacturing, Distribution and Commercial. It also includes oversight of BioLife for plasma collection and our Vaccines business. Takeda’s Global Quality organization continually reinforces and supports the need for all quality decisions to align with our values. Takeda’s focus on quality also helps keep innovation, continuous improvement, knowledge and best practice sharing as key components in the Takeda culture.

Quality governance

Global Quality at Takeda is built on three pillars: Science, System and People, and is fully aligned with Takeda’s functions and business partners. The Quality organization is led by the Global Quality Officer, who reports to the president and CEO. The Global Quality Council provides oversight on global performance, trends and opportunities. Takeda has created a standard structure for the Quality organizations in our manufacturing sites. That way, functions, roles and responsibilities stay consistent throughout the organization.

Any Quality or Good Management Practice (GMP) compliance incident that might affect distributed products is sent to Takeda Senior Management by the global Quality Incident Management team. Quality incidents are quickly evaluated, and any necessary regulatory reporting or market actions are taken. In keeping with our “as local as possible, as global as needed” approach, we’ve established local Quality Councils, which provide oversight, monitor quality and compliance, and communicate with senior management.

Quality Councils help information flow between regional/operating unit councils and Global Quality Councils, so issues get resolved at the lowest possible level and trends are more easily noticed
and addressed.

Quality strategy

Quality decisions at Takeda are always taken in alignment with our company values, with a focus on the priorities of putting the Patient first, building Trust with society, reinforcing our Reputation and supporting our Business. Quality decisions are taken transparently and in alignment with our approach to partner with all global health authorities as we maintain our favorable regulatory profile.

Global Quality has made significant progress on its Quality Roadmap in support of Takeda’s vision. The roadmap is reviewed annually and updated as needed to make sure it reflects advancements in the regulatory and pharmaceutical environment and the company strategy. In the past year, we’ve made significant progress in laboratory transformation, supplier quality management, quality incident management and defining and clarifying global versus local strategies, all while working to maintain a positive regulatory profile and delivering innovative products to our patients.

Quality Roadmap

Quality-Roadmap
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Our clinical studies are designed to protect the safety and well-being of our patients and the integrity of our clinical trial data.

Integration progress

We completed the significant task of combining our well-performing Quality Management Systems (QMS) into one harmonized system. At the same time, we designed our Global Quality organization with the combined new business in mind. Now, all our global standards and procedures are covered in a single Quality Policy that provides clarity and compliance and meets current industry expectations.

During integration, we used AGILE, a Global Manufacturing and Supply and Global Quality (GMSGQ) program specifically driving Lab & Operational Excellence, to standardize our processes and programs. We are continuing the program within the entire GMSGQ network of Takeda sites as a part of Agile 4.0. By applying Lean tools, our labs have become more efficient, and our lab analysts are more engaged and empowered to make decisions. We also harmonized a system of key metrics and planned the beginning of key Quality IT systems.

Electronic (IT) Quality systems remain a top priority. We focus on standardization, simplification and alignment with industry best practices in order to speed up systems integration, manage costs and complexity, and lay a foundation for advanced analytics. Planning is underway for our three key systems platforms.

Product quality and safety

Global Quality continually emphasizes consistency and excellence in our quality decisions throughout the company. We use best practices for research, development and safety evaluation throughout the entire product life cycle. This focus enables Takeda to develop innovative, safe and effective medicines.

Global Quality partners with R&D to ensure compliance with governing laws and regulations, as well as with our own internal rules and standards. In research and nonclinical studies, we require high data integrity standards. Our clinical studies, regardless of the phase or market where they are conducted, are designed to protect the safety and well-being of our patients and the integrity of our clinical trial data. We make sure that our studies are conducted in accordance with scientifically sound protocols and that data are collected, analyzed and reported in a transparent and responsible manner.

As our products reach the production and distribution stage, standards are just as high. All investigational medicinal products and pharmaceutical products are produced and controlled in accordance with current GMP. The integrity and security of our products are protected by our compliance with Good Distribution Practice. Once products are released, we continue to ensure quality by collecting important information from clinical investigators and the market. In this way, we work to detect potential quality issues at an early stage and build continuous improvement into our quality processes.

We monitor the safety of all Takeda products, continuously collecting safety information in the development phase of new medicines and throughout the time they are marketed. We use this information to detect any signs of safety problems. If we find a potential problem, we promptly notify health authorities, health care providers and companies marketing our products. We also provide information on appropriate product use.

 

Regulatory engagement

We work to maintain and strengthen relationships with regulatory bodies. For example, we’re active participants in a number of industry trade groups such as International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) and Pharmaceutical Research and Manufacturers of America (PhRMA). This involvement includes active contributions to working teams and proposals for improving overall current good manufacturing practices (cGMPs).

In addition, we participate in external conferences where global regulators, including the U.S. Food and Drug Administration (FDA), Brazilian Health Regulatory Agency (ANVISA) and European Medicines Agency (EMA), routinely present, and engage as applicable. Additionally, Takeda is recognized as a global leader in virology; our Global Quality Pathogen Safety team routinely works with global regulatory and medical groups in addressing pathogen safety and active approaches to addressing emerging viral agents.

Product anticounterfeiting measures

Counterfeit, falsified and other illegally traded medicines present significant threats to consumers and patients around the globe. With the growing trend of illegal operations targeting medicines used to treat and prevent complex diseases, the industry faces increasing challenges to safeguard patient health and its products. Takeda is taking a holistic, risk-based approach to identify and lessen the risks of falsified, illegal and other types of suspect products to keep our patients safe. A dedicated Global Product Protection team uses a strategic approach by collaborating with internal functions and external agencies to carry out this mission.

We partner actively with international and local law enforcement, regulatory agencies, other pharmaceutical companies and industry organizations to combat counterfeiting and illegal trading, while also educating patients, supply chain partners and customers on
the dangers associated with these activities. Through partnerships such as IFPMA “Fight the Fakes” Campaign and Alliance for Safe Online Pharmacies (ASOP), we contribute to grassroots education for patients.