CPGP 試験問題を無料オンラインアクセス

Which of the following best describes a product complaint?
Response:

• A.A report of dissatisfaction concerning a company's service.
• B.A report of a side effect experienced by a patient or consumer using a pharmaceutical product.
• C.A report of a financial loss due to the use of a product.
• D.A report of any dissatisfaction with a product's quality, identity, durability, reliability, safety, effectiveness, or performance.

Which ISO standard is commonly referenced in the context of pharmaceutical quality management?
Response:

• A.ISO 9001
• B.ISO 14001

What is the primary goal of materials control in filling operations?
Response:

• A.To maximize employee efficiency
• B.To minimize costs regardless of quality
• C.To ensure the fastest production speed
• D.To ensure the identity, strength, and purity of materials

The purpose of retaining reserve samples is to:Response:

• A.Have samples available for display purposes
• B.Ensure that there is always an excess of product
• C.Meet regulatory requirements and enable future testing if needed
• D.Use them for training new laboratory personnel

Which of the following is NOT a standard or regulation relevant to the pharmaceutical industry?
Response:

• A.GSP
• B.GDP
• C.GMP
• D.GCP