Storage Quality Control of Investigational Drugs and Their Ingredients

Chugai uses the Pharmaceutical Model DX200P Data Acquisition Station for storage quality control of investigational drugs and ingredients.

Chugai Pharmaceutical's main plant, the Ukima Plant, began operation in 1957 undertaking continuous production from manufacturing of pharmaceutical ingredients to preparation and packaging. At present the factory is also engaged in technological development including production of active-ingredients using biotechnology, manufacture of pharmacological products, and development of technology for the new drug industry. It also houses the Drug Engineering Division that develops new drugs.

We visited Ms. Matsuzawa of the Quality Assurance Dept. who is in charge of storage and management of investigational drugs and other quality assurance responsibilities. Chugai uses the Pharmaceutical Model DX200P Data Acquisition Station for temperature control in the storage locations for these preparations (ingredients).

Centralized monitoring of temperature in the storage room with the DX200P

Ms. Matsuzawa: "We use freezers to store investigational drugs and active-ingredients, and the DX200P records the temperatures. We also record the temperature in the storage rooms themselves, and all the data is centrally monitored on the DX200P. We should control the temperature during storage. Base on the quality assurance the monitoring/recording the temperatures is very important." Previously Chugai used some separate chart recorders for each temperature control range, but there was an increasing demand for PC-based data analysis and electronic data management, which led them to consider switching to a paperless recorder.

Ms. Matsuzawa: "When looking for a paperless recorder, we were introduced to the DX200P. Its support for Part 11 and prevention of data tampering were big points in its favor. It also had the advantages that all the data that we used to record individually we could manage on a single unit, and that we could check all the data simply by switching the screen of each temperature control range." The DX200P complies with CFR Part 11 (a standard related to electronic recording and verification) and is a pharmaceutical-dedicated model that comes standard with data tampering prevention and login functions, providing highly reliable data recording.

Ms. Matsuzawa: "When we were using chart recorders we had to leaf through charts to check data and it was hard to find the exact portions we needed. Also, the charts were stored away from our desks, which meant that we had to walk to a distant storage location anytime we wanted to check some data. After bringing in the DX200P, the data could be transferred automatically to the server for access from our desks, and it really helped us out because we could confirm the outlier at a glance. Also, it is very convenient to be able to search for and immediately find the data we want right on the PC." Using the DX200P's FTP client function, recorded data can be automatically transferred to a server. And using the DAQSIGNIN software (comes standard), it is easy to search through files and print out specific data.

The DX200P also records and monitors temperature and other phenomena in the storage room freezers

Ms. Matsuzawa: "We've connected it to the alarm system, so if the out of control range of temperature is observed, the alarm sounds and the person in charge is immediately contacted through the contact network so that he/she can take care of the problem right away. Also,if the same situation is occurred when samples will be take out or put in, we can use a bar coder to input a message that differentiates the event from a deviation. That's really helpful." With an external output relay option, the DX200P can perform relay output when alarms occur.

The DX200P comes with a multitude of functions, and the DX200P that complies with Part 11 meets the many needs of our pharmaceutical research and manufacturing customers.

Customer Introduction

Chugai Pharmaceutical Co., Ltd.

Ms. Matsuzawa
GMP Compliance Group for IMP Quality Assurance Dept.
Corporate Regulatory Compliance & Quality Assurance Div.



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