Quality assurance
Quality assurance
We have a policy, organization, employee training and others in our system to deliver reliable products to customers.
We have a policy, organization, employee training and others in our system to deliver reliable products to customers.
Fundamental Philosophy and Policies
Fundamental Philosophy and Policies
All employees of Taisho Pharmaceutical share the same principle and seriously engage in their work for the purpose of making consumers feel secure and satisfied. The principle is the Basic Principle of Quality Assurance under the management philosophy.
To realize this principle, the Company:
- At all times takes the opinions of all our consumers with the highest sincerity, and puts these into action to improve our quality and safety management;
- Acquires all the latest knowledge in response to the progress in science and diversification of products; and
- Clarifies where responsibility lies while building a cooperative organization since many departments are concerned with our business. 1 to 3 above are defined as our fundamental policy in quality assurance work.
All employees of Taisho Pharmaceutical share the same principle and seriously engage in their work for the purpose of making consumers feel secure and satisfied. The principle is the Basic Principle of Quality Assurance under the management philosophy.
To realize this principle, the Company:
- At all times takes the opinions of all our consumers with the highest sincerity, and puts these into action to improve our quality and safety management;
- Acquires all the latest knowledge in response to the progress in science and diversification of products; and
- Clarifies where responsibility lies while building a cooperative organization since many departments are concerned with our business. 1 to 3 above are defined as our fundamental policy in quality assurance work.
Basic Principle of Quality Assurance
Basic Principle of Quality Assurance
We constantly strive to ensure product efficacy and safety and to improve product quality from the consumers’ perspective. We are also dedicated to the peace of mind and satisfaction of our customers. This commitment to this responsibility is unwavering.
We constantly strive to ensure product efficacy and safety and to improve product quality from the consumers’ perspective. We are also dedicated to the peace of mind and satisfaction of our customers. This commitment to this responsibility is unwavering.
Policies for Quality Assurance
Policies for Quality Assurance
Stance: We will listen to consumers’ opinions and meet their expectations.
Technology: We will constantly aim for the most advanced technology, adopting a global perspective.
Management: We will constantly work on self-management activities that ensure the reliability of our activities.
Stance: We will listen to consumers’ opinions and meet their expectations.
Technology: We will constantly aim for the most advanced technology, adopting a global perspective.
Management: We will constantly work on self-management activities that ensure the reliability of our activities.
Quality Policy
Quality Policy
We continue to provide products high in quality, efficacy, and safety that earn the trust of our consumers, and bring them peace of mind and satisfaction.
We continue to provide products high in quality, efficacy, and safety that earn the trust of our consumers, and bring them peace of mind and satisfaction.
Building a system for quality assurance
Building a system for quality assurance
The Taisho Pharmaceutical Group has a social responsibility to deliver products, information and services that all consumers can trust.
The most important thing in fulfilling the responsibility is to obey laws and regulations throughout all processes such as R&D, manufacturing and sales and to make products that are effective, safe and high in quality. It is also important to ensure that, from a consumer’s perspective, the above processes are credible. The Taisho Pharmaceutical Group defines the above as quality assurance work.
In addition, we set up the Quality Assurance Headquarters independent of processes such as R&D, manufacturing and sales, and engage in quality assurance work. Many departments cooperate in quality assurance work and the Quality Assurance Headquarters functions as the leader of these departments.
The Taisho Pharmaceutical Group has a social responsibility to deliver products, information and services that all consumers can trust.
The most important thing in fulfilling the responsibility is to obey laws and regulations throughout all processes such as R&D, manufacturing and sales and to make products that are effective, safe and high in quality. It is also important to ensure that, from a consumer’s perspective, the above processes are credible. The Taisho Pharmaceutical Group defines the above as quality assurance work.
In addition, we set up the Quality Assurance Headquarters independent of processes such as R&D, manufacturing and sales, and engage in quality assurance work. Many departments cooperate in quality assurance work and the Quality Assurance Headquarters functions as the leader of these departments.
Operational Framework of Taisho Pharmaceutical’s Quality Assurance Headquarters
Operational Framework of Taisho Pharmaceutical’s Quality Assurance Headquarters
At domestic/overseas companies of Taisho Pharmaceutical Group
At domestic/overseas companies of Taisho Pharmaceutical Group
A high level of quality control and safety management is also important at Taisho Pharmaceutical Group companies in Japan or overseas. Taisho Pharmaceutical has a Group-wide management structure led by the head office.
We have also built a global pharmaceutical quality assurance system to deliver products, information and services to our overseas customers. We strengthen pharmacovigilance where the latest information on product safety is gathered and evaluation and reports are conducted accordingly. The head office and the Taisho Pharmaceutical Group companies cooperate with each other in this.
A high level of quality control and safety management is also important at Taisho Pharmaceutical Group companies in Japan or overseas. Taisho Pharmaceutical has a Group-wide management structure led by the head office.
We have also built a global pharmaceutical quality assurance system to deliver products, information and services to our overseas customers. We strengthen pharmacovigilance where the latest information on product safety is gathered and evaluation and reports are conducted accordingly. The head office and the Taisho Pharmaceutical Group companies cooperate with each other in this.
In employee training
In employee training
Taisho Pharmaceutical educates employees involved in quality control and postmarketing safety management. The educational procedures are based on GMP*1, GQP*2 and GVP*3 Ordinances.
Employees involved in quality control receive training to acquire the necessary knowledge as well as on-the-job training in on-site auditing. They also attend seminars by outside instructors. The quality assurance officer has responsibility for all of these educational programs.
Employees involved in postmarketing safety management receive education so that they are capable of performing their jobs properly. New employees are required to receive introductory training and pass the subsequent examination. These educational programs are provided under the control of a self-medication pharmacovigilance officer and a prescription drug pharmacovigilance officer.
Furthermore, all employees are provided with education on the prevention of drug-induced suffering, quality control and postmarketing safety management every year.
Taisho Pharmaceutical educates employees involved in quality control and postmarketing safety management. The educational procedures are based on GMP*1, GQP*2 and GVP*3 Ordinances.
Employees involved in quality control receive training to acquire the necessary knowledge as well as on-the-job training in on-site auditing. They also attend seminars by outside instructors. The quality assurance officer has responsibility for all of these educational programs.
Employees involved in postmarketing safety management receive education so that they are capable of performing their jobs properly. New employees are required to receive introductory training and pass the subsequent examination. These educational programs are provided under the control of a self-medication pharmacovigilance officer and a prescription drug pharmacovigilance officer.
Furthermore, all employees are provided with education on the prevention of drug-induced suffering, quality control and postmarketing safety management every year.
Quality is also secured by clinical trials
Quality is also secured by clinical trials
Clinical trials are studies conducted with the cooperation of patients to verify the actual effects of pharmaceuticals and other medical products.
When conducting clinical trials, we establish the framework based on relevant regulations such as the Pharmaceuticals and Medical Devices Act, ICH-GCP*4, and the GCP of the country where the trial is conducted.
For example, our policies clearly state that "the protection of the rights of trial subjects is the highest priority." Additionally, by clearly defining the responsibilities and roles of each officer and committee, we ensure the reliability of the data.
Clinical trials are studies conducted with the cooperation of patients to verify the actual effects of pharmaceuticals and other medical products.
When conducting clinical trials, we establish the framework based on relevant regulations such as the Pharmaceuticals and Medical Devices Act, ICH-GCP*4, and the GCP of the country where the trial is conducted.
For example, our policies clearly state that "the protection of the rights of trial subjects is the highest priority." Additionally, by clearly defining the responsibilities and roles of each officer and committee, we ensure the reliability of the data.
Appropriately providing information
Appropriately providing information
Operating Customer Hotline and Medical Information Center
Operating Customer Hotline and Medical Information Center
Customer Hotline receives consultation on OTC drugs available at pharmacies and drugstores, quasi-drugs that are also sold at convenience stores and supermarkets and other foods such as food for specified health uses.
Staff at Customer Hotline have qualifications as a pharmacist, a consumer affairs adviser and a hair adviser.
Customer Hotline receives consultation on OTC drugs available at pharmacies and drugstores, quasi-drugs that are also sold at convenience stores and supermarkets and other foods such as food for specified health uses.
Staff at Customer Hotline have qualifications as a pharmacist, a consumer affairs adviser and a hair adviser.
Medical Information Center receives consultation on ethical drugs.
Pharmacists collaborate with the sales, development, research, factory, and branch departments to provide reliable information to our customers.
Medical Information Center receives consultation on ethical drugs.
Pharmacists collaborate with the sales, development, research, factory, and branch departments to provide reliable information to our customers.
Feedback from customers to these offices is archived into a database and communicated to related departments so that it works in the development and improvement of products and improvement of services.
Feedback from customers to these offices is archived into a database and communicated to related departments so that it works in the development and improvement of products and improvement of services.
Establishing Promotion Code and transparency guidelines
Establishing Promotion Code and transparency guidelines
The Taisho Pharmaceutical Group, a drug manufacturer, needs to sincerely cooperate with medical institutions throughout the entire process from R&D to product manufacturing and launch. So we established Promotion Code, the code of conduct for securing high ethics and transparency (ensuring the absence of anything that is unclear in a process, etc.).
Whenever disclosing information, we follow Transparency Guideline for the Relation between Corporate Activities and Medical Institutions laid down by the Japan Pharmaceutical Manufacturers Association, a trade organization, and Transparency Guideline for the Relation between OTC Drug Companies’ Activities and Medical Institutions established by the Japan Self-Medication Industry.
The Taisho Pharmaceutical Group, a drug manufacturer, needs to sincerely cooperate with medical institutions throughout the entire process from R&D to product manufacturing and launch. So we established Promotion Code, the code of conduct for securing high ethics and transparency (ensuring the absence of anything that is unclear in a process, etc.).
Whenever disclosing information, we follow Transparency Guideline for the Relation between Corporate Activities and Medical Institutions laid down by the Japan Pharmaceutical Manufacturers Association, a trade organization, and Transparency Guideline for the Relation between OTC Drug Companies’ Activities and Medical Institutions established by the Japan Self-Medication Industry.
About transparency of clinical trial data
About transparency of clinical trial data
The Taisho Pharmaceutical Group discloses clinical trial data and results on the following website.
The Taisho Pharmaceutical Group discloses clinical trial data and results on the following website.
Allowing healthcare professionals, patients and many other people to access clinical trial data is important for public health as well. We believe such data should be disclosed in order to ensure the transparency of a clinical trial.
In disclosing trial data, we protect individuals’ privacy, intellectual property rights and contractual rights based on related laws and regulations in different countries.
Allowing healthcare professionals, patients and many other people to access clinical trial data is important for public health as well. We believe such data should be disclosed in order to ensure the transparency of a clinical trial.
In disclosing trial data, we protect individuals’ privacy, intellectual property rights and contractual rights based on related laws and regulations in different countries.
Notes and Additional Information
*1 GMP Ordinance: Abbreviation for Good Manufacturing Practice. Officially, it is named "Ministerial ordinance on manufacturing control and quality control standards for pharmaceuticals and quasi-drugs."
*2 GQP Ordinance: Stands for Good Quality Practice. Its official name is "Ministerial ordinance on standards for quality control for drugs, quasi-drugs, cosmetics and regenerative medicine products."
*3 GVP Ordinance: Stands for Good Vigilance Practice. Officially, the ordinance is named "Ministerial ordinance on after-sales safety management for drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine products"
*4 ICH-GCP: Good Clinical Practice (GCP) defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Notes and Additional Information
*1 GMP Ordinance: Abbreviation for Good Manufacturing Practice. Officially, it is named "Ministerial ordinance on manufacturing control and quality control standards for pharmaceuticals and quasi-drugs."
*2 GQP Ordinance: Stands for Good Quality Practice. Its official name is "Ministerial ordinance on standards for quality control for drugs, quasi-drugs, cosmetics and regenerative medicine products."
*3 GVP Ordinance: Stands for Good Vigilance Practice. Officially, the ordinance is named "Ministerial ordinance on after-sales safety management for drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine products"
*4 ICH-GCP: Good Clinical Practice (GCP) defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
