Exam: cGMP, Quality Assurance & Validation

#1 Advanced Level

What is the acceptable differential pressure typically maintained between an aseptic cleanroom suite and an adjoining lower-grade corridor to prevent airborne contamination?

A. 0 to 2 Pascals B. 10 to 15 Pascals (positive pressure) C. Negative 50 Pascals D. Pressure does not matter if HEPA filters are present

#2 Beginner Level

In process validation, what does "Prospective Validation" mean?

A. Validation conducted during routine commercial production after 20 batches. B. Validation conducted prior to the distribution of either a new product or a product made under a modified production process. C. Validation based strictly on historic batch review data. D. Validation performed exclusively when an audit finding is issued.

#3 Intermediate Level

According to EU GMP / ISO 14644-1, which air cleanliness classification is mandatory for high-risk aseptic operations such as filling sterile ampoules/vials?

A. Grade D (ISO Class 8) B. Grade C (ISO Class 7) C. Grade B (ISO Class 5 at rest) D. Grade A (ISO Class 4.8 / laminar airflow zone)

#4 Intermediate Level

What is the primary difference between a "Deviation" and an "Out of Specification (OOS)" event?

A. Deviations only apply to QC testing, while OOS applies only to manufacturing shop floor. B. A Deviation is any unplanned departure from an approved procedure (SOP/BMR), whereas OOS specifically refers to test results falling outside established acceptance criteria. C. Deviations are always permanent changes, while OOS is always temporary. D. Deviations do not require CAPA investigations, while OOS always requires them.

#5 Intermediate Level

Under WHO cGMP guidelines, what does the data integrity acronym "ALCOA" stand for?

A. Attributable, Legible, Contemporaneous, Original, and Accurate B. Authorized, Logical, Continuous, Operational, and Audited C. Applicable, Linear, Consistent, Official, and Authentic D. Attributable, Logged, Calibrated, Organized, and Archive-ready