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Quality Assurance System (Pharmaceutical Business)

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.