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About Meiji

At a Glance

At a Glance

Get to know Meiji at a glance – from our core business to our most important numbers.

Pharmaceuticals

R&D

Medical needs are always diversifying – here's how Meiji is responding.

Quality and Safety

Ensure Product Quality and Safety

Safety System Initiatives for Trusted Quality, Brand Recognition (Food Segment)

Quality Policy

Meiji Co., Ltd. has established its own quality management system, Meiji Quality Communication ("Meiji Quality Comm"). This system is founded in the Meiji Group's System of Principles, and we are strengthening our quality initiatives on a daily basis.

Meiji Quality Comm has issued a Quality Policy, which provides Meiji's principles and guidelines as they pertain to quality management.

Meiji's Quality Policy

We intend to widen the world of "Tastiness and Enjoyment" to meet all expectations of "Health and Reassurance," providing our customers with the Promised Quality they deserve. As Food and Health professionals, each and every one of us shall be responsible for meeting customer expectations according to three central principles:

  1. We will implement the best system possible in each organization, from development and design, to procurement, to production, to logistics, to sales and communication, to ensure Promised Quality.
  2. We will always be sincere and forthright in our dealings with our customers, and earn their trust and satisfaction.
  3. We will remain vigilant in complying with laws and regulations, providing safe, high-quality products and services.

Quality Management System

Our Quality Assurance Regulations, founded in our Quality Policy, clearly stipulate important items with regard to safeguarding quality in a range of duties for our functional divisions, from development and design, to procurement, to production, to logistics, to sales and communication. In addition, our Quality Assurance Standards detail specific duties and decision-making criteria. Through these, we continue to make improvements via the management cycle in all functional areas, from development and design to sales and communication, in order to gain the trust and satisfaction of our customers. Our top management also reviews these activities in assessment of our quality activities.

Meiji Quality Comm serves as Meiji Co., Ltd.'s shared posture in pursuit of customer satisfaction.

Figure: Quality Policy

Quality Management Structure

We promote quality activities centered on the Meiji Quality Communication Review, a biannual meeting chaired Chief Operating Officer of the Food Segment. At this meeting, we check the progress of our quality-related initiatives and discuss measures to resolve any issues that may be present. In addition, we have established the Meiji Quality Communication Liaison Committee, headed by the Director of the Quality Assurance Division, to plan and promote Meiji Quality Communication Advancement Activities.

Meiji Co., Ltd. also has its own Food Safety Committee, chaired by the Director of the R & D Division. This committee meets twice a year, engaging in discussion on a wide range of topics with participation from two external experts in areas like chemical substances and microorganisms in food. The body aims to identify and reduce potential risks in food products.

Figure: Quality Management Structure

Initiatives via the Value Chain

Meiji Quality Comm: Overview by Process

  1. Development and Design Functions
    Our Meiji Quality Comm quality management system is engaged in various processes beginning in the product development stage. This system asks, how can we create products offering value to our customers? To answer that question, we are diligently conducting a series of studies into markets and their consumers, meanwhile consistently advancing research and development founded in our accumulated expertise. Crafting a concept for our product becomes a key driver affecting all downstream functions, such as manufacturing and distribution.
  2. Procurement Function
    When selecting raw materials, safety and consistency are key. While safety is a naturally essential element, even a good raw material must be consistent in its availability in order for us to also be consistent in manufacturing the resulting products. Therefore, we must ensure that we can consistently secure raw materials meeting the applicable standards. In order to achieve this, trust and communication with suppliers is extremely important.
  3. Production Function
    Within the various production processes ongoing in our plants, we have established a system to ensure safety and to build quality into our products. In order to enable production with consistent product quality versus initial designs, we provide a detailed set of instructions for each product, such as raw material mixing, process conditions, and check points. In addition, we carry out inspections and monitoring at each process step, from receipt of raw materials to mixing and filling, and a control system is in place to verify that production follows the process conditions laid out in the initial design.
  4. Logistics Function
    Our logistic teams are tasked with delivering finished products from our plants to distribution centers used by dealers, wholesalers, and mass retailers. When practicing quality control, there are five key words: The five key words in practicing quality control are "product," "quantity," "freshness," "time," and "behavior." These are the "Five Promises," areas of key attention we have established to satisfy our customers and ensure that they can enjoy our products' deliciousness. We provide quality assurance through each and every one of us maintaining a keen awareness of these promises.
  5. Sales and Communication Functions
    The major role of these functions is to provide a clear, accurate picture of the value of our products to the customer in a way that shares the consumer viewpoint, as well as to share that value with them. The mission for these functions is to communicate the high quality that we have built up through the functions from development and design, to procurement, to production, to logistics. These teams are the final runner in our quality relay race, helping customers select our products knowing their value.

Food Safety Efforts

As part of our food safety efforts, we have introduced HACCP at all of our plants. In addition, in FYE March 2021, we achieved 100% acquisition worldwide of standards recognized by GFSI, a global food safety management organization.

Obtaining Anti-doping Certification for Sports Nutrition Products

The Meiji Group has obtained Informed Choice certification, a global anti-doping certification program, for the majority of our sports nutrition products. Based on the program, through analysis using advanced technologies and manufacturing process audits, products are checked to ensure they are not contaminated with any banned substances. We will continue providing certified products for athletes so that they can consume without concern as they strive to achieve their goals, and also for sports lovers.

Logo: Informed Chohice Photo: SAVAS Whey Protein 100

SAVAS Whey Protein 100 (cocoa flavor), with Informed Choice certification

Quality Training for Employees

In order to further improve quality, we hold quality training for both sales representatives and employees involved in production.

In the future, we will continue holding such seminars, and will ensure that we always share information regarding product quality and safety with our customers.

<FYE 3/2022 Training Activities>

  • Quality training for sales representatives: held biannually (number of attendees per session: approximately 1,500)
  • Basic lecture series on quality control for plant employees: 12 sessions per year (number of attendees per session: approximately 6,600)
  • Quality assurance meetings for section managers at plants: held annually (number of attendees: 86)

Quality Management Based on Reliability Assurance Systems (Pharmaceutical Segment)

Reliability assurance system (Meiji Seika Pharma)

Meiji Seika Pharma has established a system for the research, development, and stable supply of world-class products, as well as a system to collect safety information and provide information on proper use. Through this reliability assurance system, we will contribute to society by earning the trust of patients and healthcare professionals.

Meiji Seika Pharma Reliability Assurance Policy

Meiji Seika Pharma has established its Meiji Seika Pharma Reliability Assurance Policy, as follows. We conduct our business with the full recognition of the meaning and the role of this policy.

Meiji Seika Pharma will make efforts to be trusted by patients and healthcare professionals and contribute to society.
In the areas of pharmaceuticals and medical devices, we conduct our business activities with the aim of contributing to society by developing useful and high-quality products; ensuring production and stable product supplies to patients and healthcare professionals and providing necessary and prompt product information to them.
To achieve this aim, we thoroughly comply with applicable regulations and standards, as well as other social or ethical requirements, and act ethically and morally as persons involved in a life-related industry.
All of us will continue to make sincere and humble efforts to offer safe use of products and information to patients and healthcare professionals.
To work together, we ask our business partners to understand the aforementioned attitude.
With this policy for business activities to assure the reliability of our products and information provided to patients and healthcare professionals, we will continue to make efforts to have their trust and contribute to society.

Reliability Assurance Guideline

Product Initiatives

Meiji Seika Pharma is taking actions to improve the reliability of its products. Here, we define "products" to include not only the products themselves (pharmaceuticals and medical devices, hereinafter collectively "pharmaceuticals, etc."), but also data obtained through development, clinical trials, and other processes, as well as information on proper use after launched. The Meiji Seika Pharma Reliability Assurance Guideline form the foundation of these actions.

Meiji Seika Pharma Reliability Assurance Guideline

With the underlying policy (Meiji Seika Pharma Reliability Assurance Policy) of "earning the trust of patients and healthcare professionals, and contributing to society," we have established the Meiji Seika Pharma Reliability Assurance Guideline and take actions to ensure the reliability of our products.
In addition, regulatory authorities have set rigorous standards for pharmaceuticals, etc., from development to manufacturing, shipment, collection of information on adverse events, and provision of information on proper use. Based on these standards, we have established in-house standards and procedures to ensure tests are executed properly and test data is accurately collected, and we are working to improve the reliability of our data and information. These guidelines are also applied to Group companies*.

* (Domestic) OHKURA Pharmaceutical Co., Ltd./ Me Pharma Co., Ltd.
(Overseas) Meiji Pharma (Shandong) Co., Ltd./ Shantou SEZ Meiji Pharmaceuticals Co., Ltd./ PT. Meiji Indonesian Pharmaceutical Industries/ Thai Meiji Pharmaceutical Co., Ltd./ Medreich Limited /Meiji Pharma Spain, S.A.

Figure: Reliability assurance system

GCP: Good Clinical Practice
GMP: Good Manufacturing Practice
GQP: Good Quality Practice
GVP: Good Vigilance Practice
GPSP: Good Post-marketing Study Practice
QMS: Quality Management System
GDP: Good Distribution Practice

Plan-Do-Check-Act (PDCA) Cycle

Based on these guidelines, the Reliability & Quality Assurance Division serves to investigate and provide guidance to all Group companies regarding their compliance status with laws, regulations, and various standards concerning of the development, production, supply and pharmacovigilance of our pharmaceuticals, thereby promoting product reliability assurance. The Reliability & Quality Assurance Division operates independently of our development, production, and sales divisions, creating a system ensuring reliability based on objective judgment. Furthermore, in order to not only ensure but also improve the reliability of our products, we have established the Operational Rules of Quality Management Review as a tool to make continuous improvements while utilizing the PDCA cycle.
In order to improve the reliability of our products, the Operational Rules of Quality Management Review stipulate that each division shall set its own quality policies and targets to achieve, and that the management team shall be the core driver in periodically reviewing how well these targets have been achieved continuously improving quality through the PDCA cycle.

Figure: Quality management review

Quality Assurance System

As well as complying with Good Manufacturing Practice (GMP) in Japan, Europe, and the United States, Meiji Seika Pharma has established its Quality assurance policy, a policy for quality of products sold under the Meiji brand name and existing under the Meiji Seika Pharma Reliability Assurance Guideline. This policy is also applied to our products other than pharmaceuticals(ex, medical devices). By sharing this policy with Meiji Seika Pharma's fellow Group companies, we will reduce potential risks related to product quality at each stage of production (manufacturing control and quality control) and implement a global-standard quality system by practicing continuous quality improvement.

Furthermore, we are advancing consistent quality assurance activities based on our Quality assurance policy throughout the entire supply chain, from raw material procurement to production, distribution and other operations. For example, in order to safeguard product quality, we conduct audits not only at our in-house plants, but also at contract manufacturers and raw material suppliers in Japan and overseas, and provide risk reduction guidance on a regular basis.

In addition, when shipping pharmaceuticals to the market, our quality assurance managers check all manufacturing records in accordance with the law before approving their shipment. This system is in place so that we can deliver pharmaceuticals that patients and healthcare professionals can use with peace of mind.

Safety Management System

Meiji Seika Pharma strives to minimize safety risks by collecting safety information (e.g., information on adverse events) from Japan and overseas related to the pharmaceuticals, medical devices delivered to customers, objectively evaluating and reviewing this information, and promptly providing the information necessary for the proper use of its products.

In addition, we are working to improve the safety and reliability of our products by providing information on post-marketing use results surveys to medical professionals.

Quality Improvement and Personnel Development

We foster the ability of our employees to improve operations proactively. We hold meetings to share and discuss the achievements of quality improvement activities and engage in other activities to develop our personnel.

Response to Quality-Related Incidents

If a quality-related incident occurs, our head office collects quality information from plants, affiliated companies, and the respective divisions involved. This information is summarized and shared with senior management. We take any necessary measures and implement preventive measures as promptly as possible.

Concerning Response to Business Improvement Order

During the process of the investigation of the Kobayashi Kako itraconazole contamination incident that occurred in December 2020, it was discovered that the stability test data used in the registration application for rosuvastatin tablets, which were developed jointly with Kobayashi Kako and registered by Meiji Seika Pharma, had been modified.
As a result, a Business Improvement Order was issued by the Ministry of Health, Labour, and Welfare (MHLW) in May 2021. In response, we issued a business improvement plan in June 2021.
Subsequently, in accordance with the business improvement plan, we created a business procedure manual for joint development partners, conducted education and training to ensure comprehension of those procedures, improved the details of joint development agreements, and reinforced reliability audits for registration application materials. We take this Business Improvement Order extremely seriously and will work to restore our credibility.

Quality Assurance Training for Employees

Meiji Seika Pharma provides GVP compliance education for all employees and continuous education and training for GVP and GQP personnel.

<FYE 3/2022 Training Activities>

Conducted every month with the aim of permeation and strengthening of the legal compliance system in connection with revisions of the Pharmaceutical Affairs Act effective August 1, 2021 requiring establishment of a legal compliance system to ensure reliance.
GVP compliance Training (e-learning) for all employees (number of attendees: 2,200)

Attendance rate
8/2021 9/2021 10/2021 11/2021 12/2021 1/2022 2/2022 3/2022
98% 97% 98% 100% 100% 100% 100% 100%

KM Biologics holds lectures on GMP compliance annually for all employees, and holds training regarding our pharmaceutical quality management system. Our aim is to help each and every employee realize that paying close attention to how to best manage quality at each worksite leads to quality improvements overall.

<FYE 3/2022 Training Activities>

  • GMP compliance training for all employees: held annually (number of attendees: approximately 2,000)
  • Quality and safety training (e-learning) for all employees: held annually (number of attendees: approximately 2,000)

Supplier Audits

In the food business, we double-check compliance status of supplier production plants, with a focus on food safety and quality control systems but also including human rights and other issues. These checks are founded in the criteria of whether or not they are able to provide a stable supply of raw materials and packaging materials in conformance with relevant laws and regulations and our own standards.

In the pharmaceutical business, we check that suppliers have effective quality systems in place based on GQP and GMP, the status of their manufacturing and quality controls, the status of their facilities and equipment management, and the status of their employee education.

Number of Supplier Audits
FYE 3/2018 FYE 3/2019 FYE 3/2020 FYE 3/2021 FYE 3/2022
Meiji 98 98 80 41 82
Meiji Seika Pharma 386 314 372 368 252
KM Biologics 25 45 41 25 21
Total 509 457 493 434 355