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FDA Regulation of Cellular and Tissue-based Products

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wrtolbert

The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.

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WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
Dogs Bark, Cows Moo, Regulators Regulate... Frank Young, M.D. former FDA Commissioner
FDA History ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
FDA’s Purpose ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA “Centers” ,[object Object],[object Object],[object Object]
FDA Inspections ,[object Object],[object Object]
Foreign Regulatory Agencies ,[object Object],[object Object],[object Object],[object Object]
Information Sources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Information Sources ,[object Object],[object Object],[object Object]
The Primary Requirement / Roadblock ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Tools ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cross Regulation Themes and Concerns ,[object Object],[object Object],[object Object],[object Object],[object Object]
The Existing Regulatory Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How are Cell-Based Products Different? ,[object Object],[object Object],[object Object],[object Object]
FDA Driving Forces & Challenges for Cell Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cell and Tissue Characteristics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Regulation of Cellular and Tissue-based Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New FDA Regulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271
Regulatory Requirements for HCT/P’s
21 CFR Part 1271 Establishment Registration and Listing ,[object Object],[object Object],[object Object]
21 CFR Part 1271 Donor Eligibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Good Tissue Practices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Inspection and Enforcement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Inspection and Enforcement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Compliance to cGMPs, QSRs, and Biologics Regulations vs. cGTPs ,[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Inspections ,[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP Sanctions ,[object Object],[object Object],[object Object]
Additional Valuable cGMP Information ,[object Object],[object Object],[object Object],[object Object]
Open vs. Closed Manufacturing Systems ,[object Object],[object Object]
WRT&A
Material and Supply Flow WRT&A
WRT&A
WRT&A

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FDA Regulation of Cellular and Tissue-based Products

  • 1. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
  • 2. Dogs Bark, Cows Moo, Regulators Regulate... Frank Young, M.D. former FDA Commissioner
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  • 49. WRT&A
  • 50. Material and Supply Flow WRT&A
  • 51. WRT&A
  • 52. WRT&A