Sumika Chemical Analysis Service, Ltd (SCAS) offers a comprehensive range of analytical testing and related services to clients in the pharmaceutical industry. We have extensive experience and expertise in client audits and regulatory inspections. Our quality system and appropriate responses during inspections were well-received by many clients.
Furthermore, we proactively monitor and collect the latest information on domestic and international regulations and guidelines, as well as pharmacopoeias (Japanese Pharmacopoeia, USP, EP), to ensure compliance with regulatory requirements, including data integrity. We then implement necessary upgrades to our quality system in a timely manner.
GMP
【Regulatory inspection】
Domestic regulatory inspection record（past 5 years）
Since 2008, we have experienced numerous regulatory inspections both domestically and internationally.
(Overseas) US FDA, Europe MHRA, Brazil, South Korea, Russia
(Domestic) PMDA, Osaka Prefecture, Oita Prefecture
FDA inspection record
FDA inspection record
| Time | Inspected Facility |
| July 2010 | Oita laboratory |
| February 2012 | Oita laboratory |
| September 2014 | Oita laboratory |
| May 2015 | Osaka laboratory |
| June 2018 | Oita laboratory |
| November 2019 | Oita laboratory |
| October 2023 | Osaka laboratory |
Domestic regulatory inspection record（past 5 years）
| Time | Number |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 3 |
【Client audit】
Every year, we have quality system audits from many clients.
Client audit record（past 5 years, including remote audits）
| Time | Number |
| 2019 | 46 |
| 2020 | 32 |
| 2021 | 35 |
| 2022 | 37 |
| 2023 | 32 |
GCTP
We received the inspection for Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) to be in compliance with it (Osaka Laboratory and Oita Laboratory in 2023).
GLP
【Regulatory Investigations】
Since 1998, we regularly received a Pharmaceutical GLP Compliance Certificate from the PMDA (Pharmaceuticals and Medical Device Agency in Japan).
In addition, we received a GCP inspection by the FDA in 2022.
【Client audit】
Every year, we have quality system audits from many clients.
Client audit record（past 5 years, including remote audits）
| Time | Number |
| 2019 | 10 |
| 2020 | 6 |
| 2021 | 6 |
| 2022 | 10 |
| 2023 | 2 |
Contact Us for Services
For inquiries and requests concerning services of analysis, measurements, products and consulting, please contact us via inquiry form.