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 is the difference between 'validation' and 'qualification' in cGMP manufacturing?
Answer: Validation applies to processes; qualification applies to equipment and facilities
Qualification (IQ/OQ/PQ) demonstrates that equipment and facilities perform as intended; validation demonstrates that a process consistently produces product meeting predetermined specifications.
Under 21 CFR Part 211, what are the minimum data integrity requirements for original laboratory records?
Answer: Records must be made at the time of performance, be attributable (signed/initialed), legible, original, and accurate (ALCOA principles)
Data integrity under ALCOA requires that all records be Attributable, Legible, Contemporaneous, Original, and Accurate — these principles apply to both paper and electronic records.
What does 'GDP' (Good Documentation Practices) require when correcting an error in a paper record?
Answer: Draw a single line through the error, write the correction alongside, add initials, date, and reason for correction
GDP requires a single strikethrough that keeps the original entry readable, with the correction, signature/initials, date, and reason noted — never erasing or obscuring original entries.
What is the primary purpose of a 'Site Master File' (SMF) in pharmaceutical cGMP?
Answer: It is a comprehensive document describing a facility's GMP operations submitted to regulatory authorities to facilitate drug product approval
A Site Master File provides regulatory authorities with a comprehensive description of a manufacturing facility's GMP systems, processes, and controls to support regulatory review.
In cGMP, what is a CAPA (Corrective and Preventive Action) system designed to accomplish?
Answer: To address root causes of actual problems (corrective) and potential problems (preventive) to eliminate recurrence
CAPA addresses quality problems: corrective actions eliminate the root cause of existing non-conformances; preventive actions eliminate potential causes of problems before they occur.
What distinguishes a 'Class 100' (ISO 5) cleanroom from a 'Class 10,000' (ISO 7) cleanroom?
Answer: Class 100 has a maximum of approximately 3,520 particles ≥0.5 µm per m³ (very clean); Class 10,000 allows up to 352,000 particles per m³
Cleanroom classifications define the maximum allowable particle counts per volume of air; ISO 5 (Class 100) is far cleaner than ISO 7 (Class 10,000) and requires more stringent controls.