Lecture 14

Question 1

What is a Critical Quality Attribute (CQA)?

Answer 1

• A characteristic that impacts the quality/safety of the drug product, such as:
− A chemical, a physical, or a microbiological attribute
• Critical Quality Attributes Help Ensure Patient Safety
– The efficacy and safety of the therapeutic product is maintained over its shelf-life

Question 2

Code of Federal Regulations Title 21 (FDA)

Answer 2

• General requirements for control of the drug product are listed in CFR Title 21

Question 3

Formulation Related Critical Quality Attributes

Answer 3

• Assay/Impurities
• Solubility
• pH
• Osmolality

Question 4

Acceptable pH Range for an Injectable Product:

Answer 4

• pH 7.4 physiologically ideal, but not always feasible

* Under many conditions, injections can be dosed safely with pH as low as 4 or as high as 9

Question 5

Manufacturing Related Critical Quality Attributes

Answer 5

• Compounding
• Filling
• Microbial control
• Particulate control

Question 6

Bioburden

Answer 6

Numberofviablebacteria,yeast,and molds in a bulk product prior to sterilization (i.e. compounded solution)
- Testing: Per USP <61> test

Question 7

Sterility Testing:

Answer 7

– Drug product tested at time of production & over

its shelf-life

Question 8

Terminal Sterilization (TS)

Answer 8

Drug product is sterilized in the primary container

- Listed in USP <1229>

Question 9

If Terminal Sterilization is NOT Possible:

Answer 9

– Aseptic processing