Our Quality Assurance System
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- Our Quality Assurance System
Daito’s Quality Assurance System (1)
GMP
Since pharmaceutical products have direct impacts on the health and life of consumers, their quality is crucial.
Pharmaceutical manufacturers could not manufacture their products without complying with Good Manufacturing Practice (GMP)* standards for the manufacturing management and quality management of drugs and quasi-drugs.
Daito performs manufacturing management and quality control in compliance with three GMP principles in order to manufacture high-quality pharmaceutical products always at the same level.
Daito’s quality assurance system
We believe that our commitment to fostering “quality culture” in our Company will underpin our quality assurance system.
Since the 1980s, we have valued high quality as a “source of competitiveness” and have taken proactive measures not only to comply with the GMP standards* set by the Japanese Ministry of Health, Labor and Welfare but also to pass inspections by the U.S. Food and Drug Administration (FDA), whose criteria are said to be even more stringent than those in Japan. In this way, we have gained the trust of our business partners and patients on our medications.
Daito’s corporate culture of giving top priority to quality has taken a firm hold with no changes since then. In accordance with the Daito Quality Policy, we are engaged in business activities with our top priority given to offering pharmaceutical products that patients can take with peace of mind.
(* GMP [Good Manufacturing Practice] standards: Standards for manufacturing management and quality control for drugs and quasi-drugs)
In addition, our Information Management Unit manages computers connected to analytical devices and manufacturing equipment as required by the GMP standards, while the General Affairs and Human Resources Unit hires personnel to support production and quality management and educates employees about quality culture. Our quality assurance system is therefore supported through Company-wide activities.
Daito’s Quality Assurance System (2)
Fostering quality culture
What is quality culture?
Quality culture is a foundation for a quality assurance system. We are also committed to fostering a quality culture in order to enhance our quality assurance system.
Basic principles of quality culture
Elements and ideal of quality culture to be shared among quality assurance staff in a company
Determination
Our top priority is to protect the life of patients.
Values
Management members and employees must be aware of the need to unite to put quality first.
Action guidelines
To ensure the stable supply of safe and secure pharmaceutical products, the Company must have firmly established and currently effective organizations and systems whereby every employee can take the initiative in ensuring product quality and making appropriate decisions.
Daito’s quality culture
Since the 1980s, we have valued high product quality as a "source of competitiveness" and have recognized passing FDA inspections as the most important challenge we should solve because FDA criteria are said to be the most stringent in the world. Since 1989, we have undergone 11(Eleven) FDA inspections (a total of inspections on both APIs and formulation products). Therefore, the culture of putting quality first has permeated the Company during the long period.
At Daito, directors serve as responsible officers and hold a meeting (quality management review) at least once a month to receive regular reports from the Quality Control Unit.
Since we are manufacturing many APIs and formulation products, human errors may sometimes result in products that cannot be provided to the market. We respond to such human errors based on the principle that the cause of an error must be found in a system instead of being rooted in people. The culture of identifying the fundamental cause of a problem and "systematically" addressing its impacts on all areas has taken deep root in the Company.
If a quality assurance issue found and pointed out by an employee is not resolved, the whistleblower system will ensure that the problem will be reported directly to an in-house or external contact for consultation.
Measures to Ensure the Reliability of Generic Drugs
Inspections for consistency between the approval documents for manufacturing/marketing and the actual manufacturing and testing procedures for Generic Drugs
Reconfirmation of approval documents for manufacturing and marketing (FY2021)
We consider recent quality problems in the Japanese generic drug industry to be extremely important. Therefore, from March 2021, we worked to reconfirm that all 115 Daito products approved for manufacturing and marketing are manufactured in compliance with the specifications written on the approval documents, based on Japan Generic Medicines Association (JGA) Announcement No. 25 (dated March 25, 2021). The reconfirmation process for all products was completed in November 2021. As a result, we found no serious discrepancies.
Necessary administrative procedures based on the results of the reconfirmation of approval documents for manufacturing and marketing
Although there were no serious discrepancies between reality and the approval documents for manufacturing and marketing that we had obtained, there were slight discrepancies that did not affect product quality. In response to the results, we are following the administrative procedure for notifying the authorities of minor corrections to the relevant approval documents successively.
Daito’s Efforts to Strengthen Its Pharmaceutical Products’ Manufacturing Administration and Quality Management
Below is an announcement about Daito’s efforts to strengthen its pharmaceutical products’ manufacturing administration and quality management in response to recent quality problems in the Japanese generic drug industry.