What is the primary goal of quality assurance in pharmaceutical manufacturing?

• To ensure product safety and efficacy

• To maximize production efficiency

• To minimize costs

• To comply with regulatory requirements

Which of the following is not a component of quality assurance?

• Current Good Manufacturing Practices (cGMP)

• Quality control (QC)

• Quality risk management (QRM)

• Production planning

What is the relationship between quality assurance and quality control?

• QA is a subset of QC.

• QC is a subset of QA.

• QA and QC are separate but complementary functions.

• QA and QC have no relationship.

What is the main objective of cGMP?

• To ensure the quality and safety of pharmaceutical products

• To maximize production efficiency

• To minimize costs

• To comply with regulatory requirements

Which of the following is not a core principle of cGMP?

• Personnel

• Premises

• Equipment

• Marketing

What is the purpose of the documentation system in cGMP?

• To provide a record of all manufacturing activities

• To ensure compliance with regulatory requirements

• To improve production efficiency

• To reduce costs

What is the primary role of quality control in pharmaceutical manufacturing?

• To ensure product safety and efficacy

• To maximize production efficiency

• To minimize costs

• To comply with regulatory requirements

Which of the following is not a function of quality control?

• Sampling

• Testing

• Documentation

• Production planning

What is the purpose of the certificate of analysis (COA)?

• To provide a record of the quality control tests performed on a product

• To ensure compliance with regulatory requirements

• To improve production efficiency

• To reduce costs

What is the first step in the pharmaceutical manufacturing process?

• Formulation development

• Production planning

• Quality control testing

• Packaging