Production Control System and Quality Control System
Good Quality Practice (GQP), Good Vigilance Practice (GVP), and Good Manufacturing Practice (GMP)
As the leader in traditional medicines, Tsumura has built a management system that
enables the stable supply of high-quality pharmaceutical products, promotes their proper
use, and ensures their safety in accordance with the Pharmaceutical Affairs Act and
other relevant regulations.
With the General Manager of marketing at the hub of operations, the Quality Assurance
Department, which handles issues related to quality control and GQP regulations, and the
Product Safety & Pharmacovigilance Department, which handles GVP-related issues,
maintain a close working relationship at all times through executive meetings. The
Pharmaceutical Regulatory Department is responsible for providing legal support to these
two departments.
Tsumura's management system is equipped to provide product quality assurance, to collect
and evaluate data on product use, and to take appropriate measures as necessary, thus
fulfilling its responsibilities as a pharmaceutical company.
For the manufacturing of Kampo products that rely on natural resources, all
production-related departments assume responsibility for ensuring a stable supply of
high-quality products by complying with Good Manufacturing Practice standards, including
the pharmaceutical GMP and GMP for Kampo products.
Measures Against Residual Pesticide Contamination
To procure raw materials for crude drug of the highest quality, a minimum amount of
pesticides must be used in cultivation to protect them from pests and weeds. However,
the volume of pesticide used must be strictly controlled to prevent any potential risk
to health. Tsumura has voluntarily established a testing system for 73 pesticides that
are listed in the United States and Japanese Pharmacopoeias, and has conducted residual
pesticide testing in allaw material for crude drug batches since 2006. In addition, from
2010 Tsumura has expanded its testing to include all 191 pesticides that are currently
used in cultivation.
In addition to residual pesticide testing in crude drugs, all batches of final product
are also tested for 73 pesticides, including organochlorine, organophosphate, and
pyrethroid based chemicals. These are examples of some of the measures that Tsumura
takes to enforce stringent quality control of their products.
Quality Control of Raw Materials for Crude Drug and Final Products
Before raw materials for crude drug are accepted for use, samples from different
cultivation areas are checked for appearance and morphological properties to assess
their quality in advance. Botanical samples that pass the tests are sent to Shenzhen
Tsumura or to the Ishioka Processing & Quality Control Center for incoming material
testing. This testing is performed using thin layer chromatography in accordance with
the Japanese Pharmacopoeia, and includes tests for macroscopic and microscopic
identification, purity, arsenic, and other heavy metals, loss on drying, and
aristolochic acid. In addition, a quantitative analysis of marker components using
high-performance liquid chromatography and other in-house tests are performed as part of
the incoming material testing.
Multiple quality tests are performed in the final products as well, to verify their
batch-to-batch consistency, efficacy, and safety as pharmaceutical agents. To ensure
product batch-to-batch consistency, the condition and identity of the product, water
content, and physical properties are tested. To ensure product efficacy, marker
components and extract content are quantified. To ensure product safety, microbial
limits, residual pesticides, aristolochic acid, and purity are tested.
As explained in the section on Tsumura rikkunshito extract granules for prescription,
the computerized pharmaceutical GMP network system and the analysis of marker components
help lower the variance in product quality across the different batches to a range of 5%
to 10%.