10+ Interview Questions and Answers

Observations can be classified as critical, major, or minor based on their impact on quality and compliance.

• Critical observations have a significant impact on product quality and regulatory compliance.

• Major observations have a moderate impact on product quality and regulatory compliance.

• Minor observations have a minimal impact on product quality and regulatory compliance.

• Observations can be related to equipment, processes, documentation, or personnel.

• Examples of critical obse...read more

ANF and Nutch filter are both used in the field of information retrieval, but they have different purposes and functionalities.

• ANF (Approximate Nearest Neighbor Filtering) is a technique used to efficiently filter out irrelevant data points in a dataset based on their proximity to a query point.

• Nutch filter, on the other hand, is a component of the Apache Nutch web crawler framework that is used to filter and prioritize web pages during the crawling process.

• ANF is primarily u...read more

API stands for Active Pharmaceutical Ingredient, which is the biologically active component in a pharmaceutical drug.

• API is the main ingredient in a drug that produces the intended effects on the body.

• It is responsible for the therapeutic effects of the drug.

• Examples of APIs include paracetamol in pain relievers and ibuprofen in anti-inflammatory drugs.

Difficulties during line clearance include time constraints, equipment availability, and potential contamination risks.

• Time constraints can make it challenging to thoroughly clean and inspect the production line before starting a new batch.

• Limited availability of cleaning equipment or resources can hinder the efficiency of line clearance.

• There is a risk of cross-contamination if residues or contaminants from the previous product are not completely removed.

• Ensuring proper docu...read more

Variation guidelines for emerging and regulated countries

• Understand the regulatory landscape of each country

• Consider cultural and language differences

• Develop a flexible approach to adapt to changing regulations

• Ensure compliance with local laws and regulations

• Collaborate with local stakeholders to gain insights and build relationships

• Examples: FDA guidelines for medical devices in the US vs. CE marking in Europe

• Examples: Differences in labeling requirements for food products i...read more

Line clearance procedure is a process followed in pharmaceutical manufacturing to ensure that equipment and areas are free from any previous product or contamination before starting a new production.

• Line clearance procedure is performed to prevent cross-contamination and ensure product quality.

• It involves a series of checks and documentation to verify that the equipment, area, and materials are ready for use.

• Line clearance is typically conducted by the IPQA (In-Process Qualit...read more

Metallic particles can be identified by their shiny appearance and ability to conduct electricity, while non-metallic particles lack these properties.

• Metallic particles have a reflective surface and may appear shiny or lustrous.

• They are typically good conductors of electricity and heat.

• Examples of metallic particles include iron, copper, aluminum, and gold.

• Non-metallic particles do not have a shiny appearance and are poor conductors of electricity.

• They may have a dull or matt...read more

Nitrogen is widely used in various industries and applications due to its inert properties, non-reactivity with many substances, and ability to create an inert atmosphere.

• Nitrogen is commonly used in the food industry to prevent spoilage and maintain freshness, such as in packaging of potato chips and coffee beans.

• In the pharmaceutical industry, nitrogen is used to prevent oxidation and degradation of sensitive drugs and chemicals.

• Nitrogen is also used in the electronics indu...read more

There are three types of line clearance: equipment line clearance, product line clearance, and area line clearance.

• Equipment line clearance involves ensuring that all equipment used in a production line is properly cleaned and free from any previous product or material.

• Product line clearance involves verifying that the previous product has been completely removed from the production line before starting a new product.

• Area line clearance involves ensuring that the production a...read more

BMR in pharma stands for Batch Manufacturing Record, which is a document containing all the necessary information for the production of a specific batch of a pharmaceutical product.

• BMR includes details such as ingredients used, equipment used, manufacturing process, packaging details, and quality control checks.

• It serves as a guideline for production personnel to ensure consistency and quality in each batch.

• BMR is a crucial document for regulatory compliance and traceability ...read more

The make of compressor, chiller, thermopac, boiler, and other items vary depending on the manufacturer.

• The make of the compressor can be Carrier, Emerson, or Danfoss.

• The make of the chiller can be Trane, York, or Carrier.

• The make of the thermopac can be Thermax, Forbes Marshall, or Balkrishna.

• The make of the boiler can be Cleaver-Brooks, Fulton, or Hurst.

• The make of other items can vary depending on the specific equipment needed.

The important part of a boiler is the combustion chamber.

• The combustion chamber is where fuel is burned to produce heat.

• It is designed to efficiently burn the fuel and transfer the heat to the boiler's water or steam.

• The size and shape of the combustion chamber can vary depending on the type and size of the boiler.

• Examples of combustion chamber designs include firetube, watertube, and fluidized bed boilers.