Quality Control
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HPLC
A high-performance liquid chromatography (HPLC) instrument is a versatile analyzer of the purity of active pharmaceutical ingredients (APIs) and formulation products, the content of substances in formulation products, etc.
Our Quality Control Department has about 50 HPLC instruments.
Quantitative testing of products
We conduct physicochemical analyses to check that products contain APIs appropriately and that they do not contain unnecessary substances.
The quality of pharmaceutical products must be ensured within the manufacturing process, in principle. However, products of undesirable quality may be produced due to errors or accidents in the field of manufacturing. The Quality Assurance Department serves as the last bastion by finding such products.
Dissolution test
In a dissolution test, the process of a drug dissolving in a human body is simulated. Tablets or capsules are put into in a glass container filled with a test liquid whose pH is the same as water, gastric acid or intestinal fluids and whose temperature is maintained at 37°C. By doing so, the dissolution process of the tablets or capsules is monitored. Generic drugs are required to be as dissolvable as the original drugs. The photo shows an automated dissolution tester.
Microbial test
A microbial test is conducted to confirm that raw materials delivered to us or our APIs or formulation products are not contaminated with micro-organisms.
As of 2022, the microbial testing of formulation products are not mandatory. However, Daito conducts regular microbial tests on some products according to its original standards.
Ensuring data integrity by utilizing a LIMS
We manage quality test data using a laboratory information management system (LIMS).
A quality control analyst places a laptop on a laboratory table and enters test data directly on the LIMS while conducting an analytical test.
Since this approach ensures that all data entries and operation logs are recorded in the system, it helps ensure data integrity and prevent malicious data falsification or careless data modification.
Material testing and checks on package labeling
Checks on whether package materials suitable for pharmaceutical products are used and on whether accurate information is provided on printed labels are as important as physicochemical tests in terms of quality management.
A new requirement recently imposed on pharmaceutical manufacturers is to print a barcode on each pharmaceutical product package that will reach each individual consumer, in order to provide prescribed information. The photo (on the right) shows staff checking printed barcodes and lot numbers.
QC Technical
Daito has an organization named “QC Technical” in the Quality Control Department.
The QC Technical staff mainly work to transfer testing techniques for our products or products manufactured on a contract basis and to adapt our testing methods to changes in official standards.
Equipment suitable for highly active materials
At Daito, which has multiple factory buildings for high-potent compound products, the Quality Control Unit has equipment suitable for highly active materials.