- What does cGMP mean?
- Why GMP? Controlling processes means more predictable outcomes…
- What can be learned from the semi-conductor industry clean-room and manufacturing?
- What doesn’t fit this paradigm?
- cGMP-level manufacturing
- Predictable methods lead to predictable products
- The CFR (Code of Federal Regulations) sections on GMPs
- What is covered under cGMP?
- So what is special about biomanufacturing?
- Nano-clean water necessary for nano-pharmaceuticals
- Contaminants at the nano-level
- Can you scale up the process?
- Some quality control issues – how to test
- Correctness of size – size matters!
- Composition – atomic level analyses
- Monodispersity versus agglomeration
- Order and correctness of layers
- Correctness of zeta potentials
- Does the nanomedical system contain the correct payload?
- Targeting (and mis-targeting) specificity and sensitivity
- 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.
Biomedical Engineering Building, Rm 1083