MCQ Collection
Quality Control MCQs
Practice Quality Control questions with answers and explanations.
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Correct Answer: C. Deviation
Explanation:
Deviation is a documented departure from an approved instruction, process or expected result.
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Correct Answer: A. Specification
Explanation:
Specification is a documented set of tests, methods and acceptance criteria for a material or product.
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Correct Answer: D. Quality control
Explanation:
Quality control is operational testing and activities used to verify that materials and products meet specifications.
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Correct Answer: C. Batch record
Explanation:
Batch record is a controlled document recording manufacturing and testing history for a production batch.
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Correct Answer: B. Calibration
Explanation:
Calibration is comparison and adjustment of an instrument against a traceable standard.
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Correct Answer: D. Validation
Explanation:
Validation is documented evidence that a process, method or system consistently performs as intended.
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Correct Answer: C. Sampling plan
Explanation:
Sampling plan is a defined method for selecting representative units from a batch or population.
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Correct Answer: A. Assay
Explanation:
Assay is a quantitative test measuring the amount or potency of an active ingredient.
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Correct Answer: B. Dissolution test
Explanation:
Dissolution test is a test measuring the rate and extent of drug release from a dosage form into a medium.
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Correct Answer: C. Stability study
Explanation:
Stability study is a study evaluating how product quality changes with time under environmental conditions.
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Correct Answer: B. Assay
Explanation:
Assay is a quantitative test measuring the amount or potency of an active ingredient.
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Correct Answer: D. Dissolution test
Explanation:
Dissolution test is a test measuring the rate and extent of drug release from a dosage form into a medium.