USP 797 & 825 Overview UPDATED
ACTUAL Exam Questions and CORRECT
Answers
United State Pharmacopeia (USP) - CORRECT ANSWER - Non-profit, scientific,
independent public health organization developed by a unique process of public involvement
FDA - CORRECT ANSWER - Food and Drug Administration; approves USP standards
USP General Chapters - CORRECT ANSWER - Intended to help protect and improve the
health of people by facilitating access to high quality, safe, and beneficial medicines
USP 797 - CORRECT ANSWER - Compounded Sterile Preparations (CSP) rules &
regulations for clean room, compounding room, and ante room
USP 825 - CORRECT ANSWER - General Chapter for Radiopharmaceuticals -
Preparation, Compounding, Dispensing, and Repackaging
ISO Class 8 - CORRECT ANSWER - ISO classification for 100,000 particles per cubic
foot in the Ante-area
ISO Class 5 - CORRECT ANSWER - ISO classification for laminar airflow hood with a
maximum of one particle per cubic foot
ISO Class 7 - CORRECT ANSWER - ISO classification for Buffer Area with a maximum
of 10,000 particles per cubic foot
ISO Class 3 - CORRECT ANSWER - ISO classification equivalent to the former Class 1,
allowing a maximum of one particle per cubic foot
ACTUAL Exam Questions and CORRECT
Answers
United State Pharmacopeia (USP) - CORRECT ANSWER - Non-profit, scientific,
independent public health organization developed by a unique process of public involvement
FDA - CORRECT ANSWER - Food and Drug Administration; approves USP standards
USP General Chapters - CORRECT ANSWER - Intended to help protect and improve the
health of people by facilitating access to high quality, safe, and beneficial medicines
USP 797 - CORRECT ANSWER - Compounded Sterile Preparations (CSP) rules &
regulations for clean room, compounding room, and ante room
USP 825 - CORRECT ANSWER - General Chapter for Radiopharmaceuticals -
Preparation, Compounding, Dispensing, and Repackaging
ISO Class 8 - CORRECT ANSWER - ISO classification for 100,000 particles per cubic
foot in the Ante-area
ISO Class 5 - CORRECT ANSWER - ISO classification for laminar airflow hood with a
maximum of one particle per cubic foot
ISO Class 7 - CORRECT ANSWER - ISO classification for Buffer Area with a maximum
of 10,000 particles per cubic foot
ISO Class 3 - CORRECT ANSWER - ISO classification equivalent to the former Class 1,
allowing a maximum of one particle per cubic foot
