Providing High-Quality and Safe Products

When developing a product, it is imperative to consider “safety” and “quality,” not only its efficacy or feeling of use. Specifically, we test the safety of raw materials to be used for the product with an objective evaluation method, considering the available data and information. And based on the test result, we carefully examine several patterns of combinations of those raw materials and confirm whether they have no harmful nature and give no negative effect before determining the right combination. This testing is intended to ensure the safety of raw materials and packaging materials, also their use as a finished product.
Product design is intended to enable a product to retain its continued efficacy and quality from the time the products are delivered to the customers or patients until they finish using them. Active pharmaceutical ingredients (API) of drug products are mostly constituted of chemical substances, and such ingredients may decompose when mixed with water. Thus, not only do we develop a drug product formulation that is effective and has superior texture, we design the product so that its API and quality are stable over three to five years.* To that end, we analyze multiple formulations, assess them from various aspects, including compatibility with packaging, and conduct several tests before finalizing the formulation. Through this lengthy process, we provide our customers and patients with reliable products. 

*The shelf life varies depending on the product.

Production Planning

Looking at customers’ needs and the market and considering the production efficiency of our production facilities, we work out and adjust production planning not to cause out-of-stock or excess inventory in the market. Since the quality of a product can be maintained only within a limited period, we strive to deliver new and fresh products to customers and patients in every way possible.

All the raw materials and packaging materials received at our plants are tested and inspected following the predetermined procedures that specify test items and methods. The testing is conducted by qualified personnel who have met ROHTO’s test proficiency criteria.
In addition, we regularly audit the facilities of our suppliers who manufacture the raw materials and packaging materials based on our agreements. 

Sanitation Control

Everyone entering the plant must wash their hands and wear special gowns, shoes, hair caps, face masks, and gloves to cover their entire body.

Environment Control

In each manufacturing area, environment control is ensured by microbial testing or periodical air filter inspections.

Manufacturing Water 

Water used for manufacturing the products is tested and controlled.

Management of Equipment and Tools

We use cleaned and sterilized equipment and tools throughout the manufacturing process.

In addition to the ROHTO Group’s manufacturing environment, we pay constant attention to the production and quality control of third-party contractors for which we outsource our production. We regularly inspect these contractors to confirm that they manufacture products according to GMP (Good Manufacturing Practice) standards.

We manage and control all processes, including receipt of raw materials and packaging materials, acceptance testing, production, storage, release testing, and release for shipment of products using our manufacturing system.
In the weighing process, following the instructions from the manufacturing system, operators release the materials from the automated warehouse and transfer them to the clean room.
Operators can handle only the approved materials after the quality testing, and the manufacturing system prevents rejected materials and materials still under testing from releasing.
The labels attached to each material to be weighed are visually checked by the operators, and their barcodes are cross-checked against the registered data.
Through this procedure, the manufacturing system ensures that the correct materials are used as instructed, and we can prevent any mix-up with other materials.
Also, the weighed amount is double-checked by the operators and the manufacturing system to avoid any mismeasurement.
Each raw material is weighed individually, and the area is cleaned each time for line clearance to prevent cross-contamination.

The compounding process is performed following instructions from the manufacturing system, including the input quantity of raw materials and manufacturing water, the sequence to charge each raw material, mixing, and temperature.
Before charging each raw material, the barcode is checked against the manufacturing system to confirm that it is the correct material.
And following the instructions from the system, two operators perform the compounding operation by double-checking each procedure.
In the case of eye drops, the compounding solution is automatically filtered by an aseptic filter. Through this process, the solution becomes sterile, and the sterile solution is then stored in the holding tank.

In the filling process, the solution is filled into bottles that have passed the quality testing, and the bottles are immediately sealed with nozzles and caps to prevent contamination.
The filled containers are printed with a lot number and expiry date using the printing machine.
The manufacturing system prevents the release of containers that are rejected or are under testing. The labels of the containers are visually checked by the operators, and their barcodes are cross-checked against the registered data to prevent any mix-up with other packaging materials.

In the packaging process, labels are applied to each filled container; then, they are pillow-packed and packaged in boxes.
During the above operations, the products are 100 percent inspected by a camera to check that the labels are affixed and the regulatory-required labeling, such as the lot number or expiry date, is printed appropriately.
The packaged products are stored in a warehouse until release testing is completed.
Labeling materials used for production, such as product labels, are kept and locked in the warehouse under the supervision of the Storage Control Manager. These materials are transferred from the warehouse to the manufacturing area as needed. 

To assure the quality of the products, they are tested to check their compliance with the specifications, usability for customers, such as easiness of opening a cap, and other quality aspects.
Analytical equipment for testing is inspected for maintenance and calibrated periodically. A dedicated system is used for controlling the electronic data of the testing, assuring the integrity of the data, including preventing unauthorized access or security of data.

The data from the testing and inspection required for product release are provided to the Responsible Person for Product Release. In addition to the testing and inspection data, the Responsible Person for Product Release reviews the records of all processes, verifies that the manufacturing and quality controls have been properly conducted, and determines the product release.
Once approved for release, the products are transferred from the warehouse to a dedicated berth (staging area) for shipment and delivered to customers and patients.

Most of ROHTO’s products are shipped by carriers and delivered to customers or patients via wholesalers, retailers, or medical institutions. To assure the quality of products during transportation, we determine the specifications of the products after conducting multiple types of shipping tests to confirm that the transportation will not cause breakage, scratch, bent, leakage, or degradation of any product. Also, we take strict control so that the products are stored and transported under appropriate temperatures. To make this happen, we have set up a structure to keep close communication with our business partners through regular quality meetings, confirm the points to be checked, and identify issues for improvement. Working with these partners, we strive to ensure the quality of products delivered to our customers and patients.

Collaboration with Suppliers

Our quality control continues after the products are delivered to each store.
In cooperation with retailers who directly deliver our products to customers, we provide appropriate information to the customers and receive feedback from them and store clerks through our sales staff. In addition, we have set up a "Customer Support Desk" to receive from customers their comments, inquiries, or consultations on any quality issues, and we faithfully respond to each of them. Rohto provides customers and patients with a wide range of products, from eye care products, oral medicines, in-vitro diagnostics, and skin care products to foods. In order to correspond to questions and comments from our customers, which vary to a broad extent, Rohto’s contact desk is staffed with specialized persons with different credentials who can address them faithfully and respectfully. Further, we have had a system in place for more than 70 years to reflect customers' voices directly to our product development and to respect and share customer feedback across the entire organization. To seek higher quality and deliver safe products to our customers, we continue to work on further improvement of our products.
For drugs prescribed by medical institutions, our specialized staff provides information on proper use to the medical institutions so that doctors and patients can use them safely, abiding by laws and regulations as well as relevant guidelines. For any inquiry about a product's quality and reporting of adverse events, we have an organized structure to perform investigations promptly and properly.

Communication with Customers

In order to ensure a stable supply of high-quality products, ROHTO has obtained international certification, let alone complying with the laws, ordinances, and industry standards.
We comply with relevant countries’ laws and regulations, including the Act on Pharmaceuticals and Medical Devices of Japan, perform post-marketing quality assurance and safety management, and have a pharmacovigilance system in place to collect information on adverse events.

Marketing and Manufacturing Manager Role System Chart