Providing High-Quality and Safe Products

When developing a product, it is necessary to consider not only the product's effectiveness and usability, but also its safety and quality. For raw materials, in addition to known data and information, we conduct safety tests using objective evaluation methods, and based on these, we determine whether or not to include them in the mix after checking whether they have any harmful properties or whether there are any adverse effects from the combination. We check not only the safety of the raw materials, but also that they can be used safely as a product.
We also design our products to maintain consistent effectiveness and high quality from the moment they are delivered to the customer/patient until they are finished using them. Active pharmaceutical ingredients are often made from chemicals, and these ingredients can decompose when mixed with water. For pharmaceuticals, we develop formulations that are effective and take ease of use into consideration, while also designing them to maintain the active ingredients and quality stably for 3 to 5 years*. Before creating a single formulation, we analyze multiple formulations, evaluate them from various angles, including compatibility with containers, and pass through various testing hurdles before finally delivering a product that you can use with confidence.

*Varies by product.

Production Planning

We monitor customer and market trends, making adjustments to prevent stockouts and excess inventory in the market, and also consider production efficiency when formulating production plans. Product quality can only be maintained for a limited period of time. We strive to deliver freshly produced products to our customers and patients whenever possible.

All raw materials received at our factory are subject to a number of test items and methods, and inspections are carried out in accordance with these methods.
This inspection is carried out by qualified personnel who have passed our testing skill standards.
In addition, we conduct regular audits at raw material manufacturing sites based on agreements with manufacturers.

Sanitation control

When entering the factory, employees must wash their hands and then cover their entire body with special work clothes, shoes, hair caps, masks, gloves, etc.

Environment control

At each manufacturing workplace, we thoroughly manage the environment by regularly conducting microbiological tests and air conditioning filter inspections.

Manufacturing water

We use water for manufacturing that has been inspected and controlled.

Management of manufacturing equipment and tools

All manufacturing processes use pre-cleaned and sterilized equipment and instruments.

In addition to the manufacturing environment of the Rohto Group, we also pay attention to the production and quality control of the companies to which we outsource manufacturing. We regularly inspect these companies to ensure that they are manufacturing in accordance with GMP standards.

We use a manufacturing system to manage all processes, from receiving goods to receiving testing, manufacturing, storage, final inspection, and shipping.
In the weighing process, the raw materials to be weighed are taken out of the automated warehouse and carried into the clean room according to the production instructions of the manufacturing system.
Furthermore, workers are only allowed to handle raw materials that have passed quality testing; rejected products and raw materials undergoing testing are controlled by the manufacturing system and cannot be removed.
The labels of the raw materials to be weighed are visually checked and barcodes are verified by the manufacturing system to ensure that the raw materials are as ordered, preventing mix-ups.
Additionally, weighing values are double-checked by both the worker and the manufacturing system to prevent incorrect weighing.
To prevent cross-contamination, each component is weighed and line clearance is performed through cleaning.

The preparation process is carried out according to instructions from the manufacturing system, such as the amount of raw materials and water to be added, the order in which they are added, mixing, and temperature.
Just before each ingredient is added, its barcode is checked against the manufacturing system to confirm that it is the correct ingredient.
Then, following the instructions of the manufacturing system, two workers proceed with the preparation work, double-checking the process.
In the case of eye drops, the prepared solution is automatically filtered through a sterile filter, making the solution sterile.
The filtered chemical solution is stored in a storage tank.

In the filling process, the chemical solution is filled into containers that have passed quality testing, and then the containers are plugged and immediately capped to prevent product contamination.
Once the product is filled, the manufacturing number and expiration date are printed on the container using a stamping machine.
In addition, rejected products and containers under testing are controlled by the manufacturing system and cannot be removed.
The containers used are visually checked for labels and barcodes to prevent mix-ups.

In the packaging process, labels are attached, the product is wrapped in pillowcases, and then packed into a paper box.
All products are inspected with a camera to check whether they have labels, and whether all legally required information such as the serial number and expiration date are printed on them.
Packaged products are stored in the warehouse until shipping testing is completed.
Labels and other display materials used are stored under lock and key under the supervision of the storage manager, and are supplied to the manufacturing process from the warehouse when needed.

To guarantee the quality of the finished product, we conduct tests to check whether it meets established standards and whether it is easy to open the cap, taking into account actual customer usage scenarios.
The analytical equipment used in the tests is regularly maintained, inspected and calibrated.
We use a dedicated system for electronic test data to prevent unauthorized access, ensure data integrity, and ensure data security, ensuring the reliability of the data obtained.

All test and inspection data required for shipping is collected by the person in the quality department who makes the shipping decision.
In addition to this information, the shipping decision maker will carefully examine the records of all processes to confirm that manufacturing and quality control have been carried out appropriately, and then decide whether or not to ship the product.
Products that are determined to be ready for shipment are shipped from the warehouse to a dedicated shipping berth and delivered to the customer.

Many of Rohto Pharmaceutical's products are transported by delivery companies and delivered to customers and patients via agents, retailers, or medical institutions. To ensure quality during delivery, we conduct various transportation tests to determine product specifications after confirming in advance that there is no damage, scratches, dents, leakage, or deterioration. We also strictly manage storage and transportation at appropriate temperatures. Regarding product storage and transportation, we have established a system in which we communicate closely with our business partners through regular quality meetings, confirm management points, identify issues, and lead to improvements. We will work with our business partners to ensure the quality of the products we deliver to customers and patients.

Collaboration with business partners

Our quality control continues even after the product hits the shelves.
We work closely with retailers who deliver our products directly to customers, providing them with appropriate information. We also receive feedback from customers and retail sales staff, including customer feedback and insights from retail salespeople, through our sales staff. After products reach customers, we have established a "Customer Support Desk" to respond sincerely to any product-related comments, questions, or quality issues. We deliver a wide range of products to our customers, from eye care products to oral medications, diagnostic reagents, skin care products, and food. Our diversely qualified staff strive to respond to a wide variety of inquiries with care and sincerity. For over 70 years, we have built a system for incorporating direct customer feedback into development, and we value this feedback and have established a system for sharing it throughout the company. We strive for higher quality and continue to make improvements to ensure our customers receive peace of mind and safety.
For products prescribed by medical institutions, our specialized staff carefully explains proper usage information to the medical institutions that handle our products, and we strive to ensure that they are used safely in accordance with laws, regulations, and guidelines.We also have a system in place to quickly and appropriately investigate quality-related inquiries and adverse events.

Communication with customers

In order to ensure a stable supply of high-quality products, we comply with laws, regulations, governmental and industry standards and have obtained international certification for quality management.
We also comply with the laws and regulations of each country, including the Pharmaceutical and Medical Device Act, and have established a safety monitoring system that performs quality assurance and safety management after manufacturing and sales, and collects safety information on side effects.

[Manufacturing and sales industry: Three-role structure]