TOP PAGE > Frequently Asked Questions
Regarding the Company in General
◆ What is the relationship between CMIC and IAM?
The Institute of Applied Medicine, Inc. has been a member of the CMIC group since July, 2004.
◆ Can you attend a compliance document review after NDA in the case of PMDA (Pharmaceuticals and Medical Devices Agency) notification of a paper review?
Yes, a representative can be sent to a compliance document review at the client's request.
◆ Has IAM ever undergone inspection?
IAM is registered as an external testing facility for release testing of active pharmaceutical ingredients manufactured by companies at NDA and, therefore, has undergone on-site inspection and paper review by the PMDA and/or Hokkaido Government. IAM passed these GMP compliance inspections without comment, and also received A evaluations in all of its periodic GLP compliance reviews.
Regarding Quotations
◆ When contacting IAM regarding analytical testing for the first time, who should we contact first?
Please use the "contact form" found on the "Contact Us" page. Our sales representative will get back to you via e-mail or telephone.
◆ What are the commission charges?
For information on charges, please direct inquiries to a sales representative, or contact us using the "contact form". We will provide a quotation on receipt of study details.
◆ How long does it take to receive a quotation?
We can provide our quotation within one or two weeks of your request.
◆ Are quotations free of charge?
There is no charge for a quotation. Please feel free to contact us.
◆ Does study data remain confidential?
IAM signs nondisclosure agreements on request. Please address requests to a sales representative or contact us using the "contact form".
Reagrding Facilities/Equipment and Staff
◆ What are the differences in activities conducted in the Central Research Center and Ishikari Research Center?
Studies are conducted under the same organizational structure. We mainly conduct quality testing, microbiological testing and biotechnological testing for active pharmaceutical ingredients regardless of preparation at the Central Research Center, and quality testing for solid preparations at the Ishikari Research Center.
◆ How are stability chambers supported in case of electric power failure?
Stability chambers are supported by independent electric generators equipped with an automatic starting system as well as by an Uninterruptible Power Supply (UPS). To ensure all chambers are maintained under constant conditions, electric generators are activated between 30 seconds and one minute after electric power failure. UPS also works in the case of instantaneous power failure (only for low power recorders and humidity sensors).
◆ How are the temperatures/humidities of stability chambers monitored in the Sample Storage and Management Center?
Temperature/humidity/illumination and near-ultraviolet radiant energy are continuously monitored by dedicated strip chart recorder and by Pharmaceutical Environment Recording Monitoring System (PERMS, Yokogawa Electric Corporation), with deviations outside set point ranges resulting in an immediate alert being sent to a security company and our staff via e-mail.
◆ How are raw data and study-related materials stored after termination of the study?
In general terms, raw data are transferred to the client after termination of the study. Storage of raw data in the IAM archives can be requested for up to 10 years. Storage beyond 10 years can be negotiated (charges apply).
Study-related raw data, such as equipment maintenance logs, and temperature and humidity records, are stored by IAM for 20 years.
Regarding Studies
◆ How should test compounds be prepared for transportation to IAM?
Please contact our "Sample Storage & Management Center" staff, who will propose the most appropriate method of packaging and transporting samples.
Consideration must be given to environmental factors, such as the freezing of samples in winter and the effects of low-pressure conditions during flights, In general, an express delivery or courier service is used.
◆ What methods and controls are used for transportation of test compounds from the Sample Storage & Management Center to each research center?
Our "Sample Storage & Management Center" staff carefully transport samples using refrigerated trucks in accordance with SOP.
Temperature/Humidity is monitored with calibrated loggers during transportation. It takes 40 to 60 minutes for transportation (depending on traffic).
◆ What is the distinction between the role of the Study Director and Chief Analyst?
The Study Director, who is assigned by the Quality Control Supervisor, has overall responsibility for the assigned studies, and his/her major responsibilities include preparation of the study protocol and final report, confirmation of OOS/OOT, and communication/coordination with clients.
The Chief Analyst, who is assigned by the Study Director, is responsible for the preparation of datasheets and operating instructions, measurement readings, and confirmation of data, and reports to the Study Director. He/she also reports to and coordinates with clients.
◆ What is the distinction between the QC group and QA group?
The QC group, as the quality control unit, ensures the accuracy of the study protocol, operating instructions, data, and reports.
The QA group, as the quality assurance unit, assures the overall quality of the GMP and/or GLP system, and assures that each study meets the appropriate standards.
◆ Can clients inspect the facilities or data?
Clients are able to inspect facilities, confirm data and SOPs, and review materials related to OOT/OOS as well as unexpected accidents.