Biotech Company Departments
This is the company responsible for production of products.
Manufacturing
FDA
Food & Drug Administration
This is a controlled document that contains step by step instructions on how to perform a routine activity.
SOP
This is the U.S. agency responsible for biopharmaceuticals for use in humans.
FDA
Define "viable"
Alive; able to reproduce
This company is responsible for document control & the oversight of regulatory compliance?
SOP
Standard Operating Procedures
This is a controlled document that contains step by step instructions on how to manufacture a product.
Batch record
This is one big thing that occurs during the second step in drug development.
Testing on animals
chromatography is an example of this type of processing in biomanufacturing.
downstream processing
This company is responsible for identifying new or improved products.
Research & development
HIPAA
Health Insurance Portability & Accountability Act
This ensures documentation is accurate, complete & reliable.
Good Documentation Practices
This is one big thing that occurs during the third step in drug development.
Testing on humans
cultivation of cells is an example of this type of processing in biomanufacturing.
upstream processing
This company is responsible for conducting testing on raw materials.
CGMP
Current Good Manufacturing Practices
In reference to documentation, "contemporaneous" means...
documentation in real time
This phase in the clinical trial assess the safety & dosage of a new drug in a small group of healthy volunteers.
This is the primary purpose of conducting an audit in a biomanufacturing facility.
regulatory compliance
List the 4 biotechnology departments in a company.
1) research & development
2) quality control
3) manufacturing
4) quality assurance
NDA (list 2)
1) non-disclosure agreement
2) new drug application
ALCOA stands for..
A = attributable
L = legible
C = contemporaneous
O = original
A = accurate
List one thing that occurs during the 5th step of the drug development process.
Adds cautions/side effects
5 steps in order of drug development.
1) Drug Discovery
2) Preclinical Studies
3) Clinical Trials
4) FDA approval
5) Post marketing/research