Quality Assurance System（Pharmaceutical Business）

Sumika Chemical Analysis Service, Ltd. (SCAS) provides analytical services on various drug modalities, such as small-size molecules, medium-size molecules, biopharmaceuticals and regenerative medicine. We support pharmaceutical companies, startups, and academic institutions by offering analytical data for regulatory submissions and by performing a variety of analytical services in compliance with GMP, GLP and Japan's "Standards of Reliability of Application Data".

We continuously confirm and review the latest Japanese and international regulations and guidelines, as well as the three major pharmacopoeias (Japanese Pharmacopoeia, USP, and EP), to ensure compliance with regulatory requirements, including data integrity (DI). Accordingly, we implement updates to our quality system in a timely manner.

We have extensive experience with inspections by the US FDA, PMDA(Pharmaceuticals and Medical Device Agency in Japan) and other regulatory authorities, as well as audits by clients worldwide, and we have received positive feedback from the clients. We establish the effective Pharmaceutical Quality System (PQS) to help enhance our clients' reliability in pharmaceutical development and manufacturing.

It is important to establish the quality assurance system in compliance with the requirements of FDA, EMA and PIC/S guidance regarding Data Integrity *１(DI), and to implement DI control measures based on risk analysis. Also analytical data are required to meet the ALCOA + principles. *2　　
We establish 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

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  1 Data integrity
  A mechanism to ensure that data is complete, consistent, and accurate throughout its lifecycle.
• *
  2 ALCOA + principles
  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")
• *
  3 Analytical equipment that is compatible with data integrity
  Analytical equipment with functions to ensure data integrity and prevent unauthorized 　
  manipulation or data tampering.

Since 2008, we have experienced numerous regulatory inspections from US, Japan and other countries.
(Global) US FDA, Europe MHRA, Brazil, South Korea, Russia
(Japan) PMDA, Osaka Prefecture, Oita Prefecture

Every year, many clients visit our facilities and assess our quality system.

Since 1998, we have regularly received the Pharmaceutical GLP Compliance Certificate from the PMDA.
In addition, we received a GCP inspection by the FDA in 2022.

Every year, many clients visit our facilities and assess our quality system.

We received GCTP inspections by the PMDA and were determined to be compliant with GCTP.　(Osaka Laboratory and Oita Laboratory in 2023)