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Which of the following statements about Quality Risk Management (QRM) is correct?

During a logbook review, a QA auditor notices entries are missing dates, operator initials, and chronological order is not maintained. Which GMP principle is violated?

A company outsources analytical testing of finished products. During the PIC/S inspection, auditors request access to raw data from the contract lab. Who is responsible for ensuring compliance?

During product formulation development, the team identifies that a critical excipient may degrade under high humidity. According to ICH Q8 and Q9 guidelines, what should be the next step?

Myoglobin shows a hyperbolic binding curve because:

Consider the molecule below. Choose all statements that TRUE.

Same scenario as previous question: A tumor biopsy is processed for immunohistochemistry (IHC) to detect Ki-67, a nuclear marker of cell proliferation. The sample is incubated first with a rabbit anti–Ki-67 antibody, then with a goat anti-rabbit IgG antibody conjugated to alkaline phosphatase (AP). After adding the Fast Red substrate, red staining appears specifically in the nuclei of dividing cells. What are the roles of the primary and secondary antibodies?

Why must hemoglobin bind oxygen reversibly?

Which molecule is a reducing sugar? Mark all that applies.

Which describes the attributes of enzymes. Mark all that applies.