Good Manufacturing Practices (cGMP) Flashcards
6 cards from real BACE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Good Manufacturing Practices (cGMP) flashcards as text
What does the 'c' in 'cGMP' stand for, and why is it significant?
Answer: 'Current' indicating regulations reflect state-of-the-art technology and are updated as science advances
'Current' signifies that GMP standards evolve with technological advances — manufacturers must adopt the most up-to-date practices, not just meet historical minimum standards.
Under cGMP, what is a 'deviation' and how must it be handled?
Answer: A deviation is a departure from an approved procedure or specification that must be documented, investigated for root cause, and assessed for product impact
A deviation is any unplanned departure from approved procedures or specifications; it must be documented, investigated to find root cause, and evaluated to determine whether affected product meets quality standards.
What is the purpose of an Environmental Monitoring (EM) program in a cGMP cleanroom?
Answer: To periodically sample air, surfaces, and personnel for microbial and particulate contamination to ensure cleanroom performance
EM programs sample cleanroom air, surfaces, equipment, and personnel to detect microbial and particle contamination trends and ensure the controlled environment remains within specified limits.
In cGMP, what is a 'change control' system designed to do?
Answer: Formally evaluate, approve, document, and assess the impact of any change to a validated process, equipment, or material before implementation
Change control is a quality system that ensures all modifications to validated processes, equipment, materials, or procedures are evaluated for quality impact and formally approved before implementation.
What is 'out of specification' (OOS) in the context of cGMP testing?
Answer: Any analytical test result that falls outside the acceptance criteria established in the product specification
An OOS result is any analytical result that falls outside established acceptance criteria — requiring investigation before product disposition decisions.
Which of the following best describes the purpose of a 'batch record' in cGMP manufacturing?
Answer: A complete chronological documentation of all steps, materials, equipment, and measurements for a specific production lot
A batch record (or lot record) documents every step of manufacturing for a specific lot, including materials used (lot numbers, weights), equipment, process parameters, in-process checks, and operator signatures.