21 CFR Part 1271

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Section 351 Products • Manipulated & gene-modified products (e.g. cultured cells, CTLs, tumor vaccines • Covered under an IND • Must comply with Subparts B, C and D of <strong>1271</strong> regulations
HCT/Ps - Definition • Do not include • Vascularized organs for transplant • Whole blood & blood components • Secreted or extracted products • Minimally manipulated Bone Marrow not combined with another article • Ancillary products used in manufacturing • Animal cells & tissues & in vitro diagnostics
Page 1 and 2: 21 CFR Part 1271 Human Cells, Tissu
Page 3 and 4: Subpart A GENERAL
Page 5: Two Classes of Products • Section
Page 9 and 10: Establishment Registration • Comp
Page 11 and 12: Donor Eligibility • HCT/P must no
Page 13 and 14: Donor Screening • Screening for r
Page 15 and 16: Screening of Repeat Donor • If co
Page 17 and 18: Screening Tests - 2 • Disease age
Page 19 and 20: Use of non-conforming donors • Yo
Page 21 and 22: Products from Non-eligible Donors &
Page 23 and 24: Donor Records • The following mus
Page 25 and 26: Donor Record Contents - 2 • Recor
Page 27 and 28: Subpart C CURRENT GOOD TISSUE PRACT
Page 29 and 30: cGTP Core Requirements • Faciliti
Page 31 and 32: Quality Program Functions • Estab
Page 33 and 34: Procedures • Establish and mainta
Page 35 and 36: Facility Cleaning • Maintain in c
Page 37 and 38: Environmental Control • Control e
Page 39 and 40: Supplies & Reagents • Not used un
Page 41 and 42: Processing & Process Controls • M
Page 43 and 44: Process Validation • When process
Page 45 and 46: Storage • Storage areas controlle
Page 47 and 48: Receipt, Pre-distribution, Shipment
Page 49 and 50: Distribution - 2 • Do not make av
Page 51 and 52: Return to Inventory • Establish &
Page 53 and 54: Records Management • Must allow r
Page 55 and 56: Complaints Files • Establish & ma
Page 57 and 58:
Adverse Reaction Reports - 1 • Mu
Page 59 and 60:
HCT/P Deviations • Must report al
Page 61:
Labeling - 2 • To appear on label
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21 CFR Part 1271

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