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생명과학 eQMS 15개 항목

Cell and Gene Therapy cGTP Checklist (21 CFR 1271)

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Confirms that human cell, tissue, and cellular/tissue-based product (HCT/P) manufacturing meets Current Good Tissue Practice requirements for donor eligibility, chain of identity, and contamination prevention. Use to audit a CGT manufacturing operation.

21 CFR 127121 CFR 211FDA CGT Guidance

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Donor Eligibility

  • Is donor eligibility determined through screening and testing before product release, except under documented exceptions? *
  • Is relevant communicable disease agent testing performed using FDA-licensed or cleared tests? *
  • Is donor eligibility documentation accompanying the HCT/P at each stage? *

Chain of Identity and Custody

  • Is a unique identifier assigned that links the patient, apheresis material, and final product (chain of identity)? *
  • Is chain of custody maintained and documented across all handling, shipping, and storage steps? *
  • Are label reconciliation and identity verification performed at each critical transfer point? *
  • Is the tracking system able to trace any product from donor to recipient and back? *

Contamination Prevention

  • Are procedures in place to prevent cross-contamination and mix-ups between autologous patient lots? *
  • Are open processing steps performed under appropriate aseptic conditions? *
  • Is environmental monitoring performed in cell processing areas? *
  • Are viral vector handling and biosafety containment controls defined for gene-modified products?

Facilities, Testing, and Records

  • Are facilities and equipment maintained and controlled to prevent contamination (cGTP core requirements)? *
  • Are release tests (identity, purity, potency, sterility) defined and rapid where product shelf life is short? *
  • Are adverse reaction reports and HCT/P deviations investigated and reported as required? *
  • Are records retained for at least 10 years after product administration or distribution? *

Cell and Gene Therapy cGTP Checklist (21 CFR 1271) 체크리스트 전체 다운로드

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