Meeting cGMP Quality System Requirements for Accreditation

Case Study


When this Client tried to achieve a voluntary accreditation from an international, government-sponsored organization, they were denied accreditation due to noncompliance with required cGMPs—particularly:

  • Gaps in overall design, implementation, and compliance of quality systems;
  • Failure to comply with existing written procedures; and
  • Concerns regarding the design and operation of the cell processing facility.

Hitachi Chemical Advanced Therapeutics Solutions was contracted to help overhaul the Client’s quality systems and operations. After a follow-up audit by the government-sponsored agency, the Client received the accreditation they needed to facilitate their business in a timely and cost-effective manner. See how PCT services achieved this by downloading the Quality Systems Implementation Case Study!

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