Sumika Chemical Analysis Service, Ltd (SCAS) provides reliable data for analytical needs that arise at every pharmaceutical stage, including R&D, new drug application, and sales and marketing for various drug modalities (small molecule drugs; middle molecule drugs, such as oligonucleotide therapeutics; biopharmaceuticals, such as antibody drugs; and regenerative medicine products).
We offer a comprehensive range of analytical testing and related services compliant with GLP and GMP to many clients in the pharmaceutical industry. To this end, we have established an effective pharmaceutical quality system (PQS) and are continuously working to enhance the level of quality assurance.
We proactively monitor and check the latest information on domestic and international regulations and guidelines, as well as the three pharmacopoeias (Japanese Pharmacopoeia, USP, EP), to ensure compliance with regulatory requirements, including data integrity (DI) *1. We then implement necessary upgrades to our quality system in a timely manner.
In addition, we also have extensive experience in inspections by regulatory authorities, including FDA, and audits by domestic and overseas clients. We have received positive feedback from the authorities and clients, regarding our ability to respond to the inspections.
Data Integrity
It is important to establish the quality assurance system in compliance with the requirements for DI guidelines of Japanese and overseas regulatory authorities, and DI is implemented based on risk analysis when testing drugs. It is required that the analytical data meet the ALCOA principles. *2
Sumika Chemical Analysis Service has established the quality assurance system to ensure that analytical data conform to the ALCOA principles and has been continuously introducing cutting-edge analytical equipment that is compatible with data integrity for pharmaceutical analyses. *3
*1 Data integrity
A mechanism to ensure that data is complete, consistent, and accurate throughout its lifecycle.
*2 ALCOA principles (ALCOA+)
ALCOA is an acronym based on the following five principles:
A ("Attributable"), L ("Legible"), C ("Contemporaneous"), O ("Original"), and A ("Accurate")
In addition to the core ALCOA principles, data should also be:
C ("Complete"), C ("Consistent"), E ("Enduring"), and A ("Available")
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*3 Analytical equipment compatible with data integrity
Analytical equipment with functions to ensure data integrity and prevent unauthorized manipulation or data tampering.
Record of Inspection and Audit
GMP
【Regulatory inspection】
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
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 fiscal 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 fiscal years, including remote audits)
Time | Number |
2019 | 46 |
2020 | 32 |
2021 | 35 |
2022 | 37 |
2023 | 32 |
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 fiscal 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.