Quality Assurance
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Quality Assurance Unit
For the safety and security of patients taking our medicine, the Quality Assurance Unit sees to it and ensures that we appropriately maintain the quality of both the products we manufacture in-house (APIs and formulation products) and the raw materials we use for these products.
For that purpose, the Unit is responsible for deciding what our quality policy should be and having our relevant units implement it.
One of the key tasks of the Quality Assurance Unit is to make a final decision on whether or not to market individual formulation products we manufacture in-house.*
(* Items that have obtained marketing approval)
Office area
Unlike the QC Dept., personnel in the Quality Assurance Unit work mainly at a desk.
As of May 2021, the Quality Assurance Unit had 38 employees.
This area also houses Regulatory Affairs, a department that works in close cooperation with the Quality Assurance Unit for our conformance to pharmaceutical regulations.
Document archive
Batch records and control records are important documents for ensuring the quality of manufactured APIs and formulation products.
These records are kept safe in a security-controlled document archive until the end of their legal retention periods.
Document checkout management system
This computer system prevents loss of batch records and control records when they are taken out of the archive.
An RFID tag is attached to each archived document, and an RFID antenna is installed on the ceiling to automatically record the checkout and return of the individual documents.
Reference sample storage
Reference samples refer to samples stored for future analytical testing so that quality can be evaluated in the event of a deficiency in a marketed product.
Each reference sample is stored until the end of its legal retention period under the storage conditions specified for each item. The fridge-freezer in the storage is equipped with an uninterruptible power system.
Document review
The Quality Assurance Unit conducts a secondary check of the batch records made by the Production Unit and the control records made by the QC Dept. to make sure that these records have no abnormalities.
Roller stamp
When recording sheets are issued to be filled out by production, quality, logistics, and other units, these sheets are marked with a roller stamp to prevent unauthorized duplication.
The number of recording sheets issued is also recorded and later checked against the number of recording sheets collected to make sure that there are no lost recording sheets or unauthorized recording sheets added.
Quality meeting
Discussed at this meeting are quality issues in daily production activities.
This meeting is attended by many members, including those from relevant units, to develop measures to prevent the recurrence of quality issues.
Quality Assurance Building
The new Quality Assurance Building was completed at the end of November 2021 for an increase in staff to respond to increasingly higher quality standards required by the market.
This building has a lot of equipment that supports high quality in a tangible way, including the above-mentioned document checkout management system and reference sample storage equipped with the uninterruptible power system and a meeting room designed with inspection in mind.
Rooftop solar panels, Quality Assurance Building
Designed to be environmentally friendly, the Quality Assurance Building has obtained Nearly ZEB certification, which requires energy consumption of less than 25% of conventional buildings.