Quality Control
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QC Dept.
Since formulation (pharmaceutical) products are used directly on the human body, their safety, effectiveness, and quality must be ensured. To supply high-quality APIs and formulation products that are of help to patients, Daito tests and controls the following to ensure their conformance to the specified rigorous quality standards: raw materials and solvents for APIs; API products; active ingredients (APIs) and additives for formulation products; and formulation products.
The QC Dept. submits quality analysis data necessary for the Quality Assurance Unit to conduct release testing.
APIs: (Components of) active pharmaceutical ingredients contained in formulation (drug) products
Formulation products: Drug products made by adding inactive ingredients, such as lactose and starch, to APIs and processing the mixture into tablets and granules
Office area
This is a work space for about 100 members of the QC Dept.
When this area was refurbished in September 2020, we set up a document archive there to store analytical records in anticipation of a future increase in written materials to maintain.
Raw material testing
We test and control the quality of raw materials and solvents for APIs and the quality of active ingredients (APIs) and additives for formulation products to ensure that they conform to quality standards.
• Microscope: Foreign matter contamination testing of raw materials (upper left)
• Inductively coupled plasma - mass spectrometry(ICP-MS): Quantification of elements that need to be controlled (lower left)
• Gas chromatograph: Identification and quantification of various impurities (right)
Physicochemical testing
We test and control the quality of API products and formulation products to ensure that they conform to quality standards.
• Sample preparation (upper left)
• (Ultra-) high-performance liquid chromatograph: Quantification of active ingredients and identification and quantification of impurities (right)
• ICP-MS: Quantification of elemental impurities (lower left)
Visual inspection
We also test consumer boxes and various labeling and packaging materials for each pharmaceutical product to ensure that their dimensions conform to standards and that printed barcodes and lot numbering are free of typographical or printing errors.
• Acceptance testing: Inspection of purchased packaging materials (left)
• Packaging test of final products: Inspection of the barcodes and lot numbering printed in the in-house packaging process (right)
Microbial test
A microbial test checks for the presence and number of bacteria and fungi in APIs and formulation products to avoid their microbial contamination.
Depending on the type of microorganism to check and count, we choose appropriate test conditions and media.
When conducting a microbial test on highly active materials, workers are wearing protective clothing for two reasons: to prevent any microorganisms on their body or clothes from affecting the test and to protect themselves from the highly active materials.
Testing of high potent compound products
Some APIs and formulation products, including anti-cancer agents, have high efficacy even in small amounts. When testing these highly active materials, we use a dedicated laboratory and dedicated laboratory instruments.
When handling tablets and other formulation products that have no risk of scattering, you don’t need to wear protective clothing, so we just wear gloves, goggles, and masks.
When handling highly active APIs that have a risk of scattering, we wear full coverage protective clothing, gloves, goggles, and masks.
• Dissolution test: Confirmation of effectiveness, safety, and quality of formulation products (upper left)
• (Ultra-) high-performance liquid chromatograph: Quantification of active ingredients and identification and quantification of any impurities contained (lower left)
• For environmental protection, we certainly collect waste liquids containing highly active materials and have an external specialized contractor dispose of the liquids (right).
High Potent R&D Center
In 2017, Daito newly set up the High Potent R&D Center to promote the development of high potent compound products, including anti-cancer agents.
On the first floor is a laboratory for APIs, and on the third floor is a laboratory for formulation products.
On the second floor is a room for trial production of formulation products, where we consider new items to develop and sometimes manufacture investigational medicinal products (IMPs).