10+ Notified Area Interview Questions and Answers

Method development can be started by defining the objectives, selecting appropriate techniques, and conducting feasibility studies.

• Define the objectives of the method development process.

• Select appropriate techniques based on the objectives and requirements.

• Conduct feasibility studies to determine the practicality and effectiveness of the chosen techniques.

• Iterate and refine the method based on feedback and results.

• Document the method development process for future reference ...read more

Method validation parameters are criteria used to ensure that a method is reliable, accurate, and reproducible.

• Parameters include accuracy, precision, specificity, linearity, range, limit of detection, limit of quantitation, robustness, and ruggedness.

• Accuracy refers to how close the measured value is to the true value.

• Precision is the degree of agreement between repeated measurements.

• Specificity measures the ability of the method to differentiate the analyte from other compo...read more

Dissolution multimedia study involves analyzing the breakdown of a substance in various media.

• Dissolution refers to the process of a substance breaking down in a liquid medium.

• Multimedia study involves analyzing this process in different types of media such as water, acid, etc.

• The study helps in understanding how a substance dissolves and its rate of dissolution.

• Examples include studying how a pill dissolves in the stomach or how a chemical compound breaks down in different s...read more

Stability stages refer to the different phases of stability that an organization goes through in its lifecycle.

• Stability stages include startup, growth, maturity, and decline.

• During the startup stage, the organization is establishing itself and working towards stability.

• In the growth stage, the organization experiences rapid expansion and increased market share.

• The maturity stage is characterized by stable operations and a well-established market presence.

• Decline stage involv...read more

Karl Fischer is a method used to determine the water content in a sample.

• Karl Fischer titration is a widely used technique in analytical chemistry.

• It involves the reaction of water with iodine and sulfur dioxide in a solvent.

• The amount of water present in the sample is determined by the amount of reagent consumed in the reaction.

• Karl Fischer titration is highly accurate and sensitive, making it ideal for measuring trace amounts of water.

Dissolution is the process of formally ending a company or organization.

• Dissolution involves liquidating assets, paying off debts, and distributing remaining funds to shareholders or members.

• It requires filing dissolution paperwork with the appropriate government agency.

• Dissolution can be voluntary, where the company decides to close, or involuntary, where it is forced to close by external factors.

• Example: A company decides to dissolve due to financial difficulties and distri...read more

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.

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

• Tablets

• Capsules

• Powders

• Granules

• Lozenges