Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

A process is ultimately validated to ensure which of the following?

A. The process meets the regulatory requirements.

B. The process meets the quality system requirements.

C. The process consistently produces the desired results.

D. The process consistently meets the desiredQuantity standards

A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

A. Recommend an immediate product recall.

B. Compare the approved text with the product label

C. Notify the regulatory authority.

D. Inform the production team.

Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

A. Before the enactment of the regulation, through the industry representative

B. Before the enactment of the regulation, through formal comments gathering process

C. After the enactment of the regulation, through the industry representative

D. After the enactment of the regulation, through a product-specific meeting

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

B. No action is required since it is an off-label use.

C. Advise the senior management to send a "Dear Dr." letter.

D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

A. Certificate of GMP

B. Certificate of Free Sale

C. Certificate of Pharmaceutical Product

D. Certificate of Analysis for the finished product

According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

A. 3

B. 5

C. 7

D. 9

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

A. Transfer the notice of the upcoming international monograph change to QA for further processing.

B. Prepare the international monograph change submission first and then prepare the local change when required.

C. Confirm that the international monograph change is not related to local pharmacopeia.

D. Analyze the impact of the international monograph change on the local pharmacopeia.

The requirements for document control are located in which of the following documents?

A. ICH guidelines

B. IEC 60601

C. ISO 13485

D. WHO guidelines

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

A. Fishbone analysis

B. Failure modes, effects, and criticality analysis

C. Fault tree analysis

D. Quality by design analysis