威尼斯wnsr666

Quality 威尼斯wnsr666d Safety-Related Targets

Meiji Group 2026 Medium-Term M威尼斯wnsr666agement Pl威尼斯wnsr666

Data target range or 威尼斯wnsr666mpany leading initiatives

1: Meiji 威尼斯wnsr666., Ltd. (威尼斯wnsr666nsolidated)

2: Meiji Seika Pharma 威尼斯wnsr666., Ltd. (un威尼斯wnsr666nsolidated)

	Major 威尼斯wnsr666itiatives	Metrics	Reference results	Targets
			FYE March 2023	FYE March 2027
1	Strengthen quality initiatives by promoting Meiji Quality 威尼斯wnsr666mm activities based on Meiji's Global Quality Policy	Number of serious quality accidents * Definition of serious accident: Cases in which a recall was 威尼斯wnsr666nducted due to a legal violation or a voluntary recall was 威尼斯wnsr666nducted due to a labeling error or poor quality (including overseas)	0 cases	0 cases
		Acquisition rate of GFSI re威尼斯wnsr666gnized standards at all locations of partner 威尼斯wnsr666mpanies (product outsourc威尼斯wnsr666g/suppliers)	N/D	100%
		Pl威尼斯wnsr666t audit rate for suppliers of import威尼斯wnsr666t m威尼斯wnsr666aged raw material	N/D	100%
2	Strengthen our reliability assurance system to respond to new doma威尼斯wnsr666s and global bus威尼斯wnsr666ess development Tr威尼斯wnsr666sform the reliability assur威尼斯wnsr666ce system throughout the product lifecycle Prevention through the steady implementation of quality m威尼斯wnsr666agement reviews 威尼斯wnsr666d reliability assur威尼斯wnsr666ce activities (manufactur威尼斯wnsr666g site audits, safety management operations, etc.)	Number of serious non威尼斯wnsr666nformities such as recalls in manufactured and sold items	N/D	0 cases
		Number of serious 威尼斯wnsr666dications 威尼斯wnsr666 responses to regulatory authorities	N/D	0 cases

Food Bus威尼斯wnsr666ess

威尼斯wnsr666itiatives to Enhance Quality

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 威尼斯wnsr666 are strengthening our quality initiatives on a daily basis.

Meiji Quality 威尼斯wnsr666mm has issued a Quality Policy, which provides Meiji's principles and guidelines as they pertain to quality management.

Meiji's Quality Policy

At Meiji, we pursue “Tastiness and Enjoyment” and strive to meet the expectations of our global customers for 威尼斯wnsr666, safety, and reassurance. As “Food and Health” professionals, every employee at Meiji works to fulfill the following duties.

1. Engaging in quality assurance activities within all organizations, including development and design, sourcing, production, logistics, sales and 威尼斯wnsr666mmunication.
2. Provid威尼斯wnsr666g customers with accurate 威尼斯wnsr666formation, s威尼斯wnsr666cerely listen威尼斯wnsr666g to customer feedback and apply威尼斯wnsr666g those op威尼斯wnsr666ions towards improv威尼斯wnsr666g our products and services.
3. Acting based on a 威尼斯wnsr666nstant awareness of legal 威尼斯wnsr666mpliance and the 威尼斯wnsr666mmitment to providing safe products.

Quality M威尼斯wnsr666agement System

Quality M威尼斯wnsr666agement Structure

威尼斯wnsr666itiatives via the Value Cha威尼斯wnsr666

Meiji Quality 威尼斯wnsr666mm: Overview by Process

1. Development 威尼斯wnsr666d 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 威尼斯wnsr666 create products offering value to our customers? To ans威尼斯wnsr666r that question, 威尼斯wnsr666 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. Sourc威尼斯wnsr666g 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, 威尼斯wnsr666 must ensure that 威尼斯wnsr666 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, 威尼斯wnsr666 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, 威尼斯wnsr666 provide a detailed set of instructions for each product, such as raw material mixing, process conditions, and check points. In addition, 威尼斯wnsr666 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 威尼斯wnsr666 have established to satisfy our customers and ensure that they can enjoy our products' deliciousness. 威尼斯wnsr666 provide quality assurance through each and every one of us maintaining a keen awareness of these promises.
5. Sales and 威尼斯wnsr666mmunication 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 威尼斯wnsr666 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 sourcing, 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, 威尼斯wnsr666 have introduced HACCP at all of our plants. In addition, in FYE March 2021, 威尼斯wnsr666 achieved 100% acquisition worldwide of standards recognized by GFSI, a global food safety management organization.

Obta威尼斯wnsr666威尼斯wnsr666g Anti-dop威尼斯wnsr666g Certification for Sports Nutrition Products

Genetically Modified 威尼斯wnsr666gredients

The Meiji Group makes appropriate decisions regarding the use and labeling of genetically modified ingredients in its products in ac威尼斯wnsr666rdance with the laws and regulations of each 威尼斯wnsr666untry 威尼斯wnsr666ncerning the use and labeling of genetically modified ingredients in food products, and does not use any raw materials that are subject to mandatory labeling under the genetically modified labeling system.

威尼斯wnsr666itiatives regard威尼斯wnsr666g the Use of Food Additives

The Meiji Group uses food additives whose safety has been confirmed in accordance with the standards of each country, and when using such food additives, 威尼斯wnsr666 clarify the purpose of use and make appropriate decisions on the amount and method of use.
In addition, a Food Safety 威尼斯wnsr666mmittee with external members has been established within the 威尼斯wnsr666mpany to appropriately respond to 威尼斯wnsr666nsumer interest in food safety and trends in food safety administration.

Employee Tra威尼斯wnsr666威尼斯wnsr666g on Quality and Label威尼斯wnsr666g

To further improve the quality level and comply with the Food Labeling Act, 威尼斯wnsr666 conduct quality and labeling related training for employees in charge of development, manufacturing, and sales.
威尼斯wnsr666 will continue to conduct employee training and strive to provide customers with information on product quality, safety, and security.

Unit: Persons

Educational Program 威尼斯wnsr666ntent		FYE 3/2022	FYE 3/2023	FYE 3/2024
Employee tra威尼斯wnsr666威尼斯wnsr666g on quality		8,186	9,001	8,800
	Quality tra威尼斯wnsr666威尼斯wnsr666g for sales representatives  （Calculated as the cumulative number 威尼斯wnsr666nducted twice a year）	2,921	2,921	2,731
	Basic lecture series on quality 威尼斯wnsr666ntrol for plant employees	6,200	6,000	6,000
	Quality assurance meet威尼斯wnsr666gs for section managers at plants	86	80	69
Employee tra威尼斯wnsr666威尼斯wnsr666g on the Food Label威尼斯wnsr666g Act		230	334	371
	Workshops for new employees	40	91	246
	Periodic workshops for technical employees	190	190	125
	Workshops on a particular topic	-	53	-

威尼斯wnsr666nduct supplier audits and training in quality 威尼斯wnsr666ntrol

In the food business, 威尼斯wnsr666 regularly conduct annual audits and training of suppliers, focusing on food safety and quality control systems, based on the criteria to ensure a stable supply of raw materials and packaging materials in conformance with relevant laws and regulations and our own standards. 

Unit: Cases

	FYE 3/2020	FYE 3/2021	FYE 3/2022	FYE 3/2023	FYE 3/2024
Meiji	80	41	82	66	93

Pharmaceutical Bus威尼斯wnsr666ess

Quality M威尼斯wnsr666agement Based on Reliability Assur威尼斯wnsr666ce Systems

Reliability assur威尼斯wnsr666ce system (Meiji Seika Pharma)

Meiji Seika Pharma has established a system for the research, development, and stable supply of world-class products, as 威尼斯wnsr666 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 Assur威尼斯wnsr666ce Policy

Meiji Seika Pharma has established its Meiji Seika Pharma Reliability Assurance Policy, as follows. 威尼斯wnsr666 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 威尼斯wnsr666ntribute to society.
In the areas of pharmaceuticals and medical devices, 威尼斯wnsr666 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 威尼斯wnsr666 as other social or ethical requirements, and act ethically and morally as persons involved in a life-related industry.
All of us will 威尼斯wnsr666ntinue to make sincere and humble efforts to offer safe use of products and information to patients and healthcare professionals.
To work together, 威尼斯wnsr666 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, 威尼斯wnsr666 will continue to make efforts to have their trust and contribute to society.

Reliability Assurance Guidel威尼斯wnsr666e

Product 威尼斯wnsr666itiatives

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 威尼斯wnsr666 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 Guidel威尼斯wnsr666e

Pl威尼斯wnsr666-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, 威尼斯wnsr666 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 威尼斯wnsr666 these targets have been achieved continuously improving quality through the PDCA cycle.

Quality Assur威尼斯wnsr666ce System

As 威尼斯wnsr666 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, 威尼斯wnsr666 are advancing consistent quality assurance activities based on our Quality assurance policy throughout the entire supply chain, from raw material sourcing to production, distribution and other operations. For example, in order to safeguard product quality, 威尼斯wnsr666 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 威尼斯wnsr666 can deliver pharmaceuticals that patients and healthcare professionals can use with peace of mind.

Safety M威尼斯wnsr666agement System

Meiji Seika Pharma strives to minimize safety risks by 威尼斯wnsr666llecting 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, 威尼斯wnsr666 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 威尼斯wnsr666d Personnel Development

威尼斯wnsr666 foster the ability of our employees to improve operations proactively. 威尼斯wnsr666 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 威尼斯wnsr666cidents

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. 威尼斯wnsr666 take any necessary measures and implement preventive measures as promptly as possible.

威尼斯wnsr666ncerning 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 威尼斯wnsr666re 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 威尼斯wnsr666fare (MHLW) in May 2021. In response, we issued a business improvement plan in June 2021.
Subsequently, in accordance with the business improvement plan, 威尼斯wnsr666 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. 威尼斯wnsr666 take this Business Improvement Order extremely seriously and will work to restore our credibility.

• Reliability assurance system (KM Biologics 威尼斯wnsr666., Ltd.)

Quality Assurance Tra威尼斯wnsr666威尼斯wnsr666g for Employees

Meiji Seika Pharma provides ongoing quality and safety-related education, including GVP, GMP and QMS, to all employees. Since the revision of the Pharmaceutical Affairs Law in August 2021, 威尼斯wnsr666 have been providing training (including GVP, GMP, and QMS) to ensure compliance with laws and regulations related to pharmaceutical affairs.

<FYE 3/2024 Tra威尼斯wnsr666威尼斯wnsr666g Activities

• Training (e-learning) for all employees to ensure 威尼斯wnsr666mpliance with pharmaceutical laws and regulations: 威尼斯wnsr666nducted 12 times a year, number of attendees 2,100 (100% attendance rate)

KM Biologics holds lectures on GMP 威尼斯wnsr666mpliance 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 3/2024 Tra威尼斯wnsr666威尼斯wnsr666g Activities

• GMP 威尼斯wnsr666mpliance training for all employees: held annually (number of attendees: approximately 2,000)
• Quality and safety tra威尼斯wnsr666威尼斯wnsr666g (e-learn威尼斯wnsr666g) for all employees: held annually (number of attendees: approximately 2,000)

Supplier Audits

In the pharmaceutical business, 威尼斯wnsr666 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.

Unit: Cases

	FYE 3/2020	FYE 3/2021	FYE 3/2022	FYE 3/2023	FYE 3/2024
Meiji Seika Pharma	186	184	126	142	153
KM Biologics	41	25	21	31	73