Quality Assurance Policy
KAKEN is committed to realizing its corporate philosophy and management policies and supplying superior pharmaceuticals. To achieve that, KAKEN will carry out the following activities in clear recognition of the fact that it is engaged in the pharmaceutical business, that it pursues higher ethical standards and that it places primary and constant emphasis on quality during the course of such activities. These activities include drug discovery, exploratory research, development, clinical trials, manufacture, post-marketing surveillance, the provision of pharmaceutical information, and other matters.
- Recognizing that product quality assurance is one of the most important issues regarding management responsibility, KAKEN will establish a pharmaceutical quality system that covers all the products it sells.
- KAKEN will provide a warranty on product quality in response to demands of customers and society.
- In order to supply patients with superior pharmaceuticals, KAKEN makes it a basic rule to comply with laws for ensuring the quality, effectiveness and safety of pharmaceuticals, medical devices and other products, as well as with other relevant laws and regulations. In addition, KAKEN follows good practices, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP), good quality practice (GQP) and good vigilance practice (GVP), and assumes responsibility for its own actions.
- KAKEN aims to establish a quality assurance system that promotes not only conformance with the standards and specifications required by regulatory authorities, but also continuous improvements that take the technological standards of the time into account.
Product Quality Assurance
KAKEN works to return smiles of happiness to the faces of as many patients as possible by supplying superior pharmaceuticals that help improve their quality of life. To that end, we believe that it is absolutely essential that we have a quality assurance system in which both our Head Office (a manufacturer and distributor of pharmaceuticals) and our factory (a manufacturer of pharmaceuticals) fulfill their respective responsibilities and cooperate closely. At our factory, competencies and appropriateness of each manufacturing process and facility are evaluated to ensure that suitable manufacturing and quality management practices are followed.
The Quality Assurance Department of the Head Office evaluates and confirms these activities, which we believe results in the creation of a more robust quality assurance system. Cooperative activities have not been limited to the departments in charge of quality, but have been expanded to the R&D Division, the Production Division and the Marketing & Sales Division to guarantee the highest quality throughout all stages of a product's lifecycle.
Safety Assurance for Pharmaceuticals after Launch
Pharmaceuticals receive regulatory approval after undergoing evaluations based on the results of clinical trials, which have a limited scope in regard to such considerations as patient age, gender, complications and concurrent medications. After launch, pharmaceuticals are used by a wider range of patients, which can reveal unexpected adverse drug reactions. For this reason, we are required to collect comprehensive safety information, accurately evaluate it and take necessary response measures.
With the establishment of the Pharmacovigilance Department, we strive to minimize the safety risks of patients by collecting and evaluating safety data throughout the product lifecycle from the development phase to post-marketing, and by providing information in a timely manner necessary for ensuring the safety of patients.
Pharmaceuticals Information Service Office
Accurate information is essential for the proper usage of prescription pharmacenticals. We provide and collect information pertaining to the proper usage of our pharmaceuticals mainly through MR activities; however, we also proactively provide and collect such information through the Pharmaceuticals Information Service Office, a consultation desk for pharmaceutical-related matters, and via our website. The office promptly and accurately informs customers about proper usage of pharmaceuticals and reports their valuable opinions and suggestions on pharmaceutical formulations and other matters to relevant departments in the Company, thereby helping to improve pharmaceutical formulations and enhance product information for the benefit of customers.
We receive most inquiries by phone; however, we provide a form on our website for receipt of inquiries, even outside office hours, with the aim of enhancing convenience for customers.