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In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

A. Potential clinical sites for the Phase III clinical trial

B. Regulatory requirements for labeling and packaging

C. Capacity of the manufacturing facilities to fully produce the new product

D. Previous actions taken by regulatory authorities on similar products

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A. Inadequate training

B. Late and/or incorrect deliverables

C. Causes of non-conformities

D. Adverse environmental impacts

A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?

A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A. The process information and analytical result of Company X API

B. The process information and analytical result of Company Y API

C. The process information and the comparative analytical result of APIs from both companies

D. Information deemed appropriate by the regulatory authority