Define quality product
Product that SATISFIES a user’s NEEDS
What are three (3) characteristics of quality products
- Customer (patient) defined
- Performance based
- Measurable
Define critical quality attributes
A quality attribute that must be controlled within defined limits to ASSURE product meets standards for (1) safety, (2) efficacy, (3) stability and (4) performance.
Define Quality by Design by FDA
systematic approach to pharmaceutical develpment to leverages (1) prior knowledge, (2) statistical models (3) mechanistic models (4) quality risk management tools
What is product failure?
measure of a lack of quality – inability of a product to SATISFY a users NEEDS
List 12 performance characteristics
- Potency
- Bioavailability
- Sterility
- Chemical stability
- Solubility
- Package leaching
- Taste
- Odor
- Appearance
- Feel
- Application
- Dose measurement
What are nine (9) performance characteristics relevant to oral administration?
NOT: Sterility, Feel, Application
- Potency
- Bioavailability
- Chemical stability
- Solubility
- Package leaching
- Taste
- Odor
- Appearance
- Dose measurement
What are ten (10) performance characteristics relevant to topical administration?
NOT: Sterility, Taste
- Potency
- Bioavailability
- Chemical stability
- Solubility
- Leaching
- Odor
- Appearance
- Feel
- Application
- Dose measurement
What are ten (1) performance characteristics relevant to ophthalmic administration?
NOT: Bioavailability, Taste
- Potency
- Sterility
- Chemical stability
- Solubility
- Package leaching
- Odor
- Appearance
- Feel
- Application
- Dose measurement
What are nine (9) performance characteristics relevant to inhaled administration?
NOT: Taste, Odor, Feel
- Potency
- Bioavailability
- Sterility
- Chemical stability
- Solubility
- Package leaching
- Appearance
- Application
- Dose measurement
What are nine (9) performance characteristics relevant to injectable administration?
NOT: Taste, Feel, Application
- Potency
- Bioavailability
- Sterility
- Chemical stability
- Solubility
- Package leaching
- Odor
- Appearance
- Dose measurement
Define isotonicity
Solution of interest has same osmotic pressure as biological solution of interest.
What are five (5) major performance considerations for IV solutions?
- Solubility
- Particulates
- Precipitation upon injection
- Dose volume
- Tightly-controlled neutral pH
- Bioavailability
What are (3) major performance considerations for IM/SQ solutions?
NOT: Dose volume, tightly-controlled neutral pH, bioavailability
- Solubiility
- Particulates
- Precipitation upon injection
Where do endotoxins come from?
In lipopolysaccharide (LPS) of cell walls of gram-negative bacteria
Name one subset of endotoxins
Pyrogens
List three (3) solvents that can be used in injectable solutions
- ethanol
- glycerin
- propylene glycol
List four (4) tonicity modifiers
- Sodium chloride
- glycerol
- mannitol
- dextrose
What is the purpose of microbrial preservatives in drug products?
Reduce proliferation of microorganisms
What types of products are microbrial preservatives included in?
Products whose formulations can support microbial growth.
List four (4) reasons pH control is important
- maximum solubility
- maximum stability
- compatibility with tissues
- compatibility with membranes
