cGMP
minimum basic requirements for study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports, and a system of quality assurance oversight to help assure product safety
Good Laboratory Practices (GLP)
Cleaning device that uses pressure and steam to sterilize lab equipment or samples for disposal
Autoclave
Document that directs operators on how to make or test the product, accompanies product/test as it is made/performed. Must be followed exactly
Batch Record/Test Record
Goal: test that evaluates the susceptibility of bacteria to antibiotics, process: uses disks on a plate of bacteria to show zone of inhibition
Kirby-Bauer Test
Bacteria stain pink, thin peptidoglycan layer
Gram negative
an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials
Good Clinical Practices (GCP)
how often should you brush teeth?
at least 2x/day
Document record of major equipment cleaning, maintenance & use, must show: date, time, product, lot number of each batch, signature
Log
Goal: Protein quantitation, process: spectrophotometry
Bradford Assay
Rod bacteria shape
Bacilli
Document that demonstrates a new drug is safe and effective for its intended use in the population studied
New Drug Application (NDA)
Cleaning such that item is safe to handle
Decontamination
Document followed for: Equipment use, cleaning & maintenance, Department responsibilities, Procedures
Standard Operating Procedure
Goal: identify specific proteins in sample, protein size, and abundance, process: nitrocellulose membrane, rocking water bath, electrophoresis
Western Blot
Bacteria stain purple, thick peptidoglycan layer
Gram positive
a process pharmaceutical companies must go through before clinical research begins
Investigational New Drug (IND) process
Eliminates most but not all pathogens
Disinfection
Responsible for ensuring compliance with CGMP, documentation
Quality Assurance (QA)
Goal: identify specific DNA sequence in a sample, process: restriction enzymes, gel electrophoresis, blot, incubate with probe, detection
Southern Blot
bacteria that occurs in clusters
staph-
Agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation
Food and Drug Administration (FDA)
Cleaning that completely eliminates all viruses, bacteria, mold, and spores
Sterilization
Responsible for testing the product to ensure its identity, safety, purity, and stability
Quality Control (QC)
Goal: identification of protein in sample, process: denatures protein, neg charge for electrophoresis, vertical electrophoresis
SDS PAGE
Spherical bacteria shape
cocci