1. Overview
1. What does cGMP mean?
2. Why GMP? Controlling processes means more predictable outcomes…
3. Enforcement
4. What can be learned from the semi-conductor industry clean-room and manufacturing?
5. What doesn’t fit this paradigm?
2. cGMP-level manufacturing
1. Predictable methods lead to predictable products
2. The CFR (Code of Federal Regulations) sections on GMPs
3. What is covered under cGMP?
3. Bionanomanufacturing
1. So what is special about biomanufacturing?
2. Nano-clean water necessary for nano-pharmaceuticals
3. Contaminants at the nano-level
4. Can you scale up the process?
4. Some quality control issues – how to test
1. Correctness of size – size matters!
2. Composition – atomic level analyses
3. Monodispersity versus agglomeration
4. Order and correctness of layers
5. Correctness of zeta potentials
6. Does the nanomedical system contain the correct payload?
7. Targeting (and mis-targeting) specificity and sensitivity

• CFR (Code of Federal Regulations) sections on GMPs.
  http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200421
  Go into the "Browse Parts" column and select Parts 200-299. The GMP sections are 210 and 211.

Researchers should cite this work as follows:

• James Leary (2007), "BME 695N Lecture 20: GMP and issues of quality control manufacture of nanodelivery systems," http://nanohub.org/resources/3529.

1. biomedical engineering 1
2. course lecture 1
3. drug delivery 1
4. nanomedicine 1
5. processing 1