Online Access Free RAC-GS Practice Test

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

• A.Isolation and purification
• B.Production of Intermediate(s)
• C.Introduction of the API starting material
• D.Physical processing and packaging

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

• A."Has the product been approved for mor&4nan 10 years?"
• B."Is the product profitable for the manufacturer?"
• C."Is the product better than currently available alternatives?"
• D."Is the product an established gold standard?"

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.Prepare the international monograph change submission first and then prepare the local change when required.
• B.Analyze the impact of the international monograph change on the local pharmacopeia.
• C.Confirm that the international monograph change is not related to local pharmacopeia.
• D.Transfer the notice of the upcoming international monograph change to QA for further processing.

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

• A.Import license
• B.Product license
• C.Export license
• D.Site license

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

• A.Quality assurance
• B.Clinical affairs
• C.Regulatory agency
• D.Quality improvement