CA BP 706 PS

What is the primary objective of Quality Assurance in the pharmaceutical industry?

• To increase product sales

• To ensure consistent product quality and safety

• To reduce production cost

• To simplify documentation

QA focuses mainly on:

• Manufacturing only

• Testing only

• Systematic prevention of errors

• Product marketing

Which of the following is not a part of QA?

• Validation

• Calibration

• Product advertisement

• Documentation

The main difference between QA and QC is:

• QA is product-based, QC is process-based

• QA is process-based, QC is product-based

• Both are the same

• QA focuses only on testing

Which department approves the Batch Manufacturing Record?

• Production

• QA

• QC

• R&D

QA ensures compliance with which of the following guidelines?

• GLP

• GMP

• GDP

• All of the above

The Quality Manual is an essential part of:

• Production process

• Quality Management System

• Marketing strategy

• Sales plan

Validation ensures that:

• Equipment is new

• Process produces desired results consistently

• Raw material is available

• Operator is trained

Granulation is mainly done to:

• Increase drug solubility

• Improve powder flow and compressibility

• Reduce tablet hardness

• Enhance disintegration

Melt granulation involves the use of:

• Organic solvents

• A binder that melts during processing

• Water-based binder

• None of the above