United States Pharmacopeia: Pharmaceutical Compound-Sterile Preparations Pt 8

Question 1

The storage area must be checked for proper room temperature once daily. Temperature fluctuations, for instance, can affect the ____ of a compound

Answer 1

stability

Question 2

Proper packaging of CSPs should be selected to ensure the packaging will maintain ____, prevent ____, and maintain ____ of the product

Answer 2

maintain sterility, prevent damage or leakage, and maintain stability

Question 3

Compounding facilities must adhere to guidelines for sterile compounding and show SOPs and proper records of ____ of products.

Answer 3

release testing

Question 4

Both CSP 1 and 2 categories prepared with sterile ingredients must be prepared using aseptic techniques, and sterility testing is not required for release. A visual inspection, using a ____ background box of the product, is required however to include checks for cloudiness, particulate matter, leakage, or container compromise. If there is an indication of compromise, the compound should be immediately discarded or isolated and a determination of what and how it occurred should be investigated

Answer 4

white and black

Question 5

If there is an indication of compromise, the compound should be immediately ____ or ____ and a determination of what and how it occurred should be investigated

Answer 5

discarded or isolated

Question 6

Processes to ensure techniques and activities demonstrate that all aspects of USP<797> guidelines are met and include a ____ of completion for each

Answer 6

verification