RAC Practice Exam 1 Solved 100% Correct

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures - ANSWER-A. The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed consent document resides with the: - ANSWER-Institutional Review Board (IRB) A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form, or strength, but anticipates that the labeling will be identical to that of the RLD. What process should be used to apply for that permission from FDA? - ANSWER-Suitability Petition A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a - ANSWER-New chemical entity when the sponsor has a right of reference to all applicable published studies Distribution records for drug products must reference or contain: - ANSWER-Name and address of the consignee A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient medication guide (MedGuide) in annotated Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical company to submit the SPL formatted labeling upon product approval? - ANSWER-14 days Adverse event reporting for a marketed biologics product is NOT required for: - ANSWER-Diagnostic non-invasive test kits The quality assurance manager of a small company consisting of 12 employees is the only internal auditor for the company and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because - ANSWER-Auditor independence has not been ensured.