simpl.
Iniciar sesión
eQMS para ciencias de la vida 15 elementos

Cell and Gene Therapy cGTP Checklist (21 CFR 1271)

Esta lista de verificación está en inglés.

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

PDF o Word gratuito · introduzca su correo electrónico para descargar.

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? *

Descargue la lista de verificación Cell and Gene Therapy cGTP Checklist (21 CFR 1271) completa

Obténgala gratis como PDF limpio e imprimible o como documento de Word editable.