Regulatory Affairs Trainee Interview Questions and Answers

A tablet is a solid dosage form of medication. The process of tablet production involves mixing active pharmaceutical ingredients with excipients and compressing the mixture into a tablet form.

• Tablets are one of the most common forms of medication.

• The production process involves several steps such as granulation, drying, blending, compression, and coating.

• Excipients such as binders, fillers, and lubricants are added to the active pharmaceutical ingredients to ensure the table...read more

Dissolution is the process by which a solid substance dissolves in a liquid, while disintegration is the breaking down of a solid dosage form into smaller particles.

• Dissolution is the process of a solid substance dissolving in a liquid to form a solution.

• Disintegration is the breaking down of a solid dosage form into smaller particles, usually in the presence of a liquid.

• Dissolution is important in drug absorption as it determines the rate at which a drug becomes available fo...read more

Physical stability refers to the ability of a product to maintain its physical characteristics over time and under various conditions.

• Physical stability is important in the pharmaceutical industry to ensure the safety and efficacy of drugs.

• Factors that can affect physical stability include temperature, humidity, light exposure, and chemical interactions.

• Physical stability testing involves monitoring a product's appearance, color, odor, texture, and other physical characterist...read more

Granulation is a process of forming granules or small particles from powder or other materials.

• It involves the use of a granulator machine to agglomerate powder particles into larger granules.

• Granulation is commonly used in the pharmaceutical industry to improve the flow and compressibility of powders for tablet manufacturing.

• There are different types of granulation techniques such as wet granulation, dry granulation, and direct compression.

• Wet granulation involves adding a l...read more