Cellular manufacturing for clinical applications

Cell-Based Therapy for Retinal Degenerative Disease

Volumn 53, Issue , 2014, Pages 178-188

  Sheu, Jonathan ^a   Klassen, Henry ^b   Bauer, Gerhard ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84925855487     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1159/000357362     Document Type: Chapter

References (46)

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17. Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. 21 CFR 210, 2013.
18. Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR 211, 2013.
19. Biological Products: General. 21 CFR 600, 2013.
20. General Biological Products Standards. CFR 610, 2013.
21. USP 36-NF 31: United States Pharmacopeia Convention. Rockville, August 1, 2013.
22. Personnel Qualifications. 21 CFR 211.25, 2013.
23. Consultants. 21 CFR 211.34, 2013.
24. Responsibilities of Quality Control Unit. 21 CFR 211.22, 2013.
25. Records. 21 CFR 600.12, 2013.
26. Written Procedures; Deviations. 21 CFR 211.100, 2013.
27. Sterility. 21 CFR 610.12, 2013.
28. Purity. 21 CFR 610.13, 2013.
29. Mycoplasma. 21 CFR 610.30, 2013.
30. Receipt and Storage of Untested Components, Drug Product Containers, and Closures. 21 CFR 211.82, 2013.
31. Control of Components and Drug Product Containers and Closures. 21 CFR 211 (Subpart E).
32. Use of Approved Components, Drug Product Containers, and Closures. 21 CFR 211.86, 2013.
33. Testing and Approval or Rejection of Components, Drug Product Containers, and Closures. 21 CFR 211.84, 2013.
34. Component, Drug Product Container, Closure, and Labeling Records. 21 CFR 211.184, 2013.
35. Automatic, Mechanical, and Electronic Equipment. 21 CFR 211.68, 2013.
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38. USP, Chapter 1116: Microbiological control and monitoring of aseptic processing environments. Pharmacopeial Forum, 2013; 36 (No 6).
39. Design and Construction Features. 21 CFR 211.42, 2013.
40. Cheney WA, Spurgin WP: Electrostatically enhanced HEPA filter. US Patent No 4,781,736. 1 Nov. 1988.
41. Ventilation, air filtration, air heating and cooling. 21 CFR 211.46, 2013.
42. Electronic Records; Electronic Signatures. 21 CFR 11, 2013.
43. Sanitation. 21 CFR 211.56, 2013.
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