Formulation & Development Executive Interview Questions and Answers

QbD stands for Quality by Design, a systematic approach to pharmaceutical development.

• Identify critical quality attributes (CQAs) of the product

• Define target product profile (TPP) and target product quality profile (TPQP)

• Design experiments to understand and control the formulation and manufacturing process

• Establish a design space within which the product will meet the desired quality attributes

• Use risk assessment and mitigation strategies throughout the development process

Excipients are inactive ingredients used in oral solid formulations to improve stability, taste, appearance, and aid in drug delivery.

• Excipients can include fillers, binders, disintegrants, lubricants, and coatings.

• Examples of excipients commonly used in oral solid formulations are microcrystalline cellulose, lactose, magnesium stearate, and hydroxypropyl cellulose.

Granulation end point is the stage in the granulation process where the desired granule size and shape is achieved.

• Granulation end point is determined by monitoring the granule size, shape, and moisture content.

• It is important to reach the granulation end point to ensure uniformity and consistency in the final product.

• Factors such as binder concentration, mixing time, and drying conditions can affect the granulation end point.

• Examples of techniques used to determine the granu...read more

Oral solids are pharmaceutical dosage forms that are intended to be taken by mouth and are in solid form.

• Tablets

• Capsules

• Powders

• Granules

• Lozenges