BME 695L Lecture 15: GMP and Issues of Quality Control Manufacture of Nanodelivery Systems

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15.1      Overview
15.1.1    What does cGMP mean?
15.1.2    Why GMP? Controlling processes means more predictable outcomes…
15.1.3    Enforcement
15.1.4    What can be learned from the semi-conductor industry clean-room and manufacturing?
15.1.5    What doesn’t fit this paradigm?

15.2      cGMP-level manufacturing
15.2.1    Predictable methods lead to predictable products
15.2.2    The CFR (Code of Federal Regulations) sections on GMPs
15.2.3    What is covered under cGMP?

15.3      Bionanomanufacturing
15.3.1    So what is special about biomanufacturing?
15.3.2    Nano-clean water necessary for nano-pharmaceuticals
15.3.3    Contaminants at the nano-level
15.3.4    Can you scale up the process?

15.4      Some quality control issues – how to test
15.4.1    Correctness of size – size matters!
15.4.2    Composition – atomic level analyses
15.4.3    Monodispersity versus agglomeration
15.4.4    Order and correctness of layers2
15.4.5    Correctness of zeta potentials
15.4.6    Does the nanomedical system contain the correct payload?
15.4.7    Targeting (and mis-targeting) specificity and sensitivity


Copyright © 2011, James F. Leary, All rights reserved.


CFR (Code of Federal Regulations) sections on GMPs. *Go into the "Browse Parts" column and select Parts 200-299. The GMP sections are 210 and 211.

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  • James Leary (2011), "BME 695L Lecture 15: GMP and Issues of Quality Control Manufacture of Nanodelivery Systems ,"

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