10+ Formulation Scientist Interview Questions and Answers

To prepare a 10% coating solution of 100 gm, 90 gm of solvent will be required.

• To prepare a 10% coating solution, the solvent will make up 90% of the total solution.

• Therefore, for 100 gm of solution, 90 gm will be solvent and 10 gm will be the coating material.

• The quantity of solvent needed will be 90 gm.

Yes, I have worked on a product with elemental impurities and resolved the issue through thorough testing and analysis.

• Identified potential sources of elemental impurities in the product

• Conducted risk assessment to determine the impact on product quality and safety

• Developed a strategy to control and monitor elemental impurities levels

• Utilized analytical techniques such as ICP-MS to quantify elemental impurities

• Implemented appropriate measures to mitigate the presence of eleme...read more

Qbd approach involves designing and developing a formulation and process based on quality attributes and risk assessment.

• Qbd stands for Quality by Design

• It involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs)

• Risk assessment is done to identify potential sources of variability and their impact on CQAs

• Formulation and process are then designed and developed to ensure consistent quality

• Example: Qbd approach for tablet formulation may invo...read more

Yes, I have worked on a product containing Nitrosamine impurity.

• I have experience in identifying and quantifying Nitrosamine impurities in pharmaceutical formulations.

• I have worked on developing strategies to minimize Nitrosamine impurities in drug products.

• I am familiar with regulatory guidelines related to Nitrosamine impurities in pharmaceuticals.

Nitrosamine impurities are a group of chemical compounds that can form during the manufacturing process of certain drugs and are considered potentially carcinogenic.

• Nitrosamine impurities are a group of chemical compounds that can form during the manufacturing process of certain drugs.

• They are considered potentially carcinogenic and are a cause for concern in the pharmaceutical industry.

• Examples of nitrosamines include N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (...read more

ICH stability guidelines provide recommendations for conducting stability studies on pharmaceutical products.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• Guidelines outline requirements for stability testing, storage conditions, and data analysis

• There are different types of stability testing including long-term, accelerated, and intermediate

• Stability data is used to determine shelf life and storage condition...read more

Challenges faced during development include formulation stability, scalability, and regulatory compliance.

• Formulation stability: Ensuring the product remains stable over time and under various conditions.

• Scalability: Adapting the formulation for large-scale production without compromising quality.

• Regulatory compliance: Meeting the strict regulations and guidelines set by authorities.

• Cost constraints: Developing cost-effective formulations without compromising efficacy.

• Ingredi...read more

Drug development process involves discovery, preclinical testing, clinical trials, regulatory approval, and post-market surveillance.

• Discovery phase involves identifying potential drug candidates through research and testing.

• Preclinical testing assesses the safety and efficacy of the drug in animals before human trials.

• Clinical trials involve testing the drug in humans to determine safety, dosage, and effectiveness.

• Regulatory approval is obtained from agencies like FDA before...read more

Excipients are selected based on their compatibility with the active ingredient, intended dosage form, and regulatory requirements.

• Consider the intended dosage form (e.g. tablet, capsule, injection) and the properties required for that form (e.g. flowability, compressibility, solubility)

• Evaluate the compatibility of excipients with the active ingredient and other excipients in the formulation

• Ensure regulatory compliance with guidelines such as the International Conference on ...read more

Principle of the instruments refers to the underlying theory or mechanism by which the instruments operate.

• Instruments work based on specific scientific principles or laws

• Understanding the principle helps in troubleshooting and optimizing instrument performance

• Examples include spectrophotometry (based on Beer-Lambert law) and chromatography (based on differential partitioning)