 |
Java Games: Flashcards, matching, concentration, and word search. |
 |
|
| A | B |
|---|
| Bioprocessing | Whole cells, enzymes, yeast, bacteria |
| Genetic engineering | Removing, modifing, adding DNA (recombinant DNA) |
| Agriculture | Crops, animal health (better yield, disease detection, food) |
| Medical/Health | New tests, vaccines, meds, diagnostics, disease tx |
| Chemical/environmental | Enzymes in detergent, plastics |
| Clinical trials | Humans |
| R&D in lab | Initial synthesis, FDA application, 3.5 yrs approx |
| Pre-clinical | Animals |
| Clinical Phase 1 | 20-80 volunteers, interaction with human body, 9-10 months, high toxicity level causes abandonment |
| Clinical Phase 2 | 100-300 pts, focus on dose-response, 1-2 yrs |
| Cinical Phase 3 | Most extensive, efficacy, dosage, safety, 100s - 1000s, compare with placeby, side effects, 2-5 yrs |
| NDA | New drug application to FDA after clinical, |
| Phase 4 | Continuation, post-marketing survey |
| stages of production | Synthesis/biosynthesis, purification, formulation, final dose/prep |
| Synthesis/biosynthesis | Raw materials, test for quality, sterilize equipment |
| Purification | Active ingredient purified, separate cells from nutrients, end result "bulk" product |
| Formulation | Mixing operations to blend active ingred with other substances, solid, capsule, table, liquid, |
| Quality Control/Quality Assurance | Ensures SOP, required by FDA, |
| Do what you say | "Follow SOP" |
| Say what you do | Write SOP down |
| Five rules for quality | Consumer needs, do what you say, say what you do, prove, improve |
| SOP | Standard Operating Procedures, detailed, length |
| Requirements of SOP | Effective date, purpose, scope, responsible, references, materials, procedures, signatures |
| Process Tech | 'on the floor" Associate's degree |
| Manfacturing | wash, dry, sterilize |
| Formulation tech | Prepare finished product |
| Process engineer | Design/develop/operate |
| Quality Control | Check raw materials (Associate or Bach) |
| QC Assistant | Analyze materials according to SOP |
| GMP | Good Manufacturing Practice |
| Validation | Ensure standards met, Masters/Doctorate |
|
|
|
|
|
|
South Central High School |
| Greenville, NC |
|
|
|
|
|
| |
