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Startup Flashcards

7 cards from real SQA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Under FDA GLP regulations (21 CFR Part 58), which startup action must be completed to establish that test and control articles are properly characterized?

    Answer: Confirming identity, strength, purity, and stability of test articles

    Test articles must be characterized for identity, strength, purity, and stability before use in a GLP study.

  2. A new SOP is needed for a procedure that will be performed during a study. When must this SOP be approved relative to study startup?

    Answer: Before the procedure is performed in the study

    SOPs must be approved and in place before any procedure they govern is conducted in the study.

  3. During startup, the QA unit reviews the Master Schedule. What is the primary purpose of this review?

    Answer: To verify the study is properly registered and scheduled

    The Master Schedule review confirms that the study is correctly registered, preventing scheduling conflicts and ensuring GLP traceability.

  4. Which element of facility readiness is most critical to verify at startup for an in-vivo GLP toxicology study?

    Answer: Animal room environmental controls (temperature, humidity, light cycles)

    Environmental conditions in animal rooms must meet protocol and regulatory requirements to ensure test system validity.

  5. What is the role of the Principal Investigator (PI) at study startup in a multi-site GLP study?

    Answer: To oversee specific phases of the study conducted at their site

    In a multi-site study, the PI is responsible for the phases of the study conducted at their facility under the Study Director's overall direction.

  6. If a GLP study protocol lacks a section describing statistical methods to be used, what should the QA unit recommend at startup?

    Answer: Request a protocol amendment to include the statistical methods before data collection

    Statistical methods must be defined in advance; a protocol amendment should be issued to include them before data generation begins.

  7. Which statement about reagent and reference standard management at study startup is consistent with GLP requirements?

    Answer: Reagents must have confirmed identity, concentration, and expiry before use

    GLP requires that all reagents and standards be properly labeled with identity, concentration, and expiry, and verified before use.

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