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KLM Laboratories

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10+ GND Solutions India Interview Questions and Answers

Updated 6 Feb 2025

Q1. What are the guidelines for a Quality Management System (QMS), and can you provide an example of any QMS activity such as a corrective action (CC), deviation, or market complaint investigation?

Ans.

Guidelines for a Quality Management System (QMS) and examples of QMS activities

  • Guidelines for QMS include establishing processes, monitoring performance, and implementing corrective actions

  • Example of a QMS activity like a corrective action could be identifying a root cause of a quality issue and implementing a solution

  • Another example could be investigating a deviation from standard procedures and implementing preventive measures

  • Market complaint investigation involves analyzin...read more

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Q2. What is your knowledge of regulatory affairs, particularly in relation to dossiers, licensing, and product permissions?

Ans.

Knowledge of regulatory affairs in relation to dossiers, licensing, and product permissions.

  • Understanding of regulatory requirements for submitting dossiers for product approval

  • Knowledge of the licensing process and requirements for different markets

  • Familiarity with obtaining product permissions from regulatory authorities

  • Experience in preparing and maintaining regulatory documentation

  • Ability to ensure compliance with regulatory standards and guidelines

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Q3. What are the guidelines for conducting hold time studies and the time periods for different stages in Oral Solid Dosage (OSD) forms?

Ans.

Hold time studies in OSD forms involve determining the time periods at different stages to ensure product quality and stability.

  • Hold time studies should be conducted to determine the maximum time a product can be held at different stages without compromising quality.

  • Different stages in OSD forms include blending, compression, coating, and packaging.

  • Hold time periods can vary depending on the specific formulation and manufacturing process.

  • For example, hold time for blending ma...read more

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Q4. What are the applications of Quality Management System (QMS) tools in the investigation process?

Ans.

QMS tools are used in the investigation process to ensure compliance with quality standards, identify root causes of issues, track corrective actions, and improve overall processes.

  • Ensuring compliance with quality standards and regulations

  • Identifying root causes of issues and implementing corrective actions

  • Tracking and documenting investigation processes

  • Improving overall processes and preventing future issues

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Q5. What are the different types of process validation and their descriptions?

Ans.

Different types of process validation include prospective validation, concurrent validation, and retrospective validation.

  • Prospective validation: Validation conducted before the process is put into routine production.

  • Concurrent validation: Validation conducted during routine production.

  • Retrospective validation: Validation conducted on processes that have been in use for some time.

  • Examples: Prospective validation would involve testing a new manufacturing process before full-sc...read more

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Q6. Tell me 5 chemical used in chemistry lab?

Ans.

Chemicals commonly used in chemistry labs include acids, bases, solvents, reagents, and indicators.

  • Acids: hydrochloric acid, sulfuric acid, nitric acid

  • Bases: sodium hydroxide, potassium hydroxide, ammonia

  • Solvents: ethanol, acetone, water

  • Reagents: iodine, bromine, silver nitrate

  • Indicators: phenolphthalein, methyl orange, litmus

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Q7. What is Aromatic and aliphatic compound?

Ans.

Aromatic compounds have a cyclic structure with alternating double bonds, while aliphatic compounds have a linear structure without double bonds.

  • Aromatic compounds are highly stable and have strong odors.

  • Aliphatic compounds are less stable and have weaker odors.

  • Examples of aromatic compounds include benzene, toluene, and naphthalene.

  • Examples of aliphatic compounds include methane, ethane, and propane.

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Q8. Tell me about pH? In detail,

Ans.

pH is a measure of acidity or alkalinity of a solution on a scale of 0-14.

  • pH stands for 'potential of hydrogen'

  • A pH of 7 is neutral, below 7 is acidic and above 7 is alkaline

  • pH is measured using a pH meter or pH paper

  • pH plays an important role in various industries such as food, cosmetics, and pharmaceuticals

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Q9. What is GTIN number??

Ans.

GTIN stands for Global Trade Item Number, a unique identifier for products used in global trade.

  • GTIN is a 14-digit number used to identify products in global trade

  • It is used to track inventory, sales, and shipments

  • GTIN can be found on product packaging or in barcodes

  • Examples of GTIN include UPC, EAN, and ISBN

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Q10. How to withdraw samples??

Ans.

Samples can be withdrawn by following proper procedures and using appropriate equipment.

  • Identify the type of sample to be withdrawn

  • Select the appropriate equipment for withdrawal

  • Follow proper procedures for withdrawal to ensure accuracy and safety

  • Label the sample correctly for identification

  • Transport the sample to the appropriate location for testing or analysis

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Q11. What is Reconciliation?

Ans.

Reconciliation is the process of comparing two sets of records to ensure they are in agreement.

  • It involves identifying and resolving discrepancies between the two sets of records.

  • Reconciliation is commonly used in accounting to ensure that financial records are accurate.

  • It can also be used in other areas such as data management and conflict resolution.

  • Examples of reconciliation include bank statement reconciliation and inventory reconciliation.

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Q12. Tel me about chromatography?

Ans.

Chromatography is a technique used to separate and analyze mixtures of chemicals.

  • It involves a stationary phase and a mobile phase.

  • The mixture is passed through the stationary phase, which separates the components based on their chemical properties.

  • Different types of chromatography include gas chromatography, liquid chromatography, and ion exchange chromatography.

  • It is commonly used in the pharmaceutical industry for drug development and quality control.

  • Chromatography can als...read more

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Q13. Tell me about benzene,

Ans.

Benzene is a colorless, highly flammable liquid with a sweet odor.

  • Benzene is a hydrocarbon with the chemical formula C6H6.

  • It is used in the production of plastics, synthetic fibers, rubber, dyes, detergents, and pharmaceuticals.

  • Exposure to benzene can cause cancer, anemia, and other health problems.

  • Benzene is also a natural component of crude oil and gasoline.

  • It is highly volatile and can easily ignite, making it a hazardous substance.

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Q14. Inprocess in cartonator

Ans.

Inprocess in cartonator refers to the stage of packaging where the product is being placed into cartons.

  • Inprocess in cartonator is a crucial stage in the packaging process as it ensures that the product is properly packaged and protected.

  • During this stage, the product is placed into the carton and any necessary inserts or instructions are added.

  • Quality checks are performed to ensure that the correct product is in the correct carton and that the carton is properly sealed.

  • Examp...read more

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Q15. Experience of pharmaceutical, handling of equipment

Ans.

I have 5 years of experience in the pharmaceutical industry, specializing in the handling of various equipment.

  • Operated and maintained pharmaceutical equipment such as tablet presses, capsule fillers, and packaging machines

  • Followed strict protocols and procedures to ensure product quality and safety

  • Troubleshooted equipment issues and performed routine maintenance to prevent breakdowns

  • Collaborated with cross-functional teams to optimize equipment performance and efficiency

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