20+ Mak Kotwal Realty Interview Questions and Answers

I respond promptly and thoroughly to any FDA observations, addressing each point and providing a plan for corrective action.

• Acknowledge the observations and thank the FDA for their feedback

• Review the observations and identify the root cause of the issue

• Develop a plan for corrective action and provide a timeline for implementation

• Communicate regularly with the FDA to provide updates on progress and ensure compliance

• Ensure that all corrective actions are documented and implemen...read more

To clear the alarm quantity label, follow these steps

• Locate the alarm quantity label on the device

• Press and hold the clear button until the label disappears

• Confirm that the alarm quantity label has been successfully cleared

Pharmacode is a barcode symbology used in pharmaceutical packaging, while Bhar Ode is not a recognized term in the field of pharmacy.

• Pharmacode is specifically designed for pharmaceutical products to encode product information like batch number and expiry date.

• Bhar Ode does not have a defined meaning in the context of pharmacy or barcode symbology.

• Pharmacode is widely used in the pharmaceutical industry for inventory management and tracking.

• Bhar Ode may be a misspelling or mi...read more

The worst issue in SCM planning is poor demand forecasting. It can lead to overstocking or stockouts, affecting customer satisfaction and profitability.

• Invest in accurate demand forecasting tools and techniques

• Collaborate with suppliers and customers to gather relevant data

• Regularly review and update demand forecasts based on market trends and customer behavior

• Implement agile supply chain strategies to quickly respond to changes in demand

• Maintain safety stock levels to mitiga...read more

Hold time period is necessary to ensure product quality and safety.

• Ensures proper curing or setting of materials used in manufacturing

• Allows for quality control checks at various stages of production

• Prevents defects or malfunctions in the final product

• Ensures compliance with industry regulations and standards

• Examples: Holding time for concrete to cure, holding time for paint to dry

When facing FDA inspectors, it is important to be prepared, knowledgeable, and professional.

• Research and understand FDA regulations and guidelines

• Ensure compliance with all applicable regulations

• Maintain accurate and up-to-date documentation

• Be prepared to answer questions and provide requested information

• Remain calm, confident, and respectful throughout the inspection

• Address any concerns or findings promptly and appropriately

Aseptic and sterile areas are environments designed to prevent contamination, with aseptic areas being cleaner than sterile areas.

• Aseptic areas are environments where contamination is minimized through practices like handwashing and wearing protective clothing.

• Sterile areas are environments where all microorganisms are eliminated, such as in an operating room.

• Aseptic areas are commonly found in pharmaceutical manufacturing facilities, while sterile areas are found in healthca...read more

The disc size of an unscrambler varies depending on the specific model and manufacturer.

• Disc size typically ranges from 12 inches to 24 inches in diameter.

• Some unscramblers may have adjustable disc sizes for different bottle sizes.

• Check the specifications provided by the manufacturer for the exact disc size of a specific unscrambler model.

I handle market complaints by actively listening to the customer, empathizing with their situation, and finding a solution that meets their needs.

• Listen attentively to the customer's complaint

• Empathize with their situation and apologize for any inconvenience caused

• Offer a solution that meets their needs and follow up to ensure their satisfaction

• Document the complaint and use it as an opportunity to improve customer service

• Train staff to handle complaints effectively and preve...read more

Leaflets are used to provide concise information and promote products or services.

• Leaflets are cost-effective marketing tools for reaching a wide audience.

• They can be easily distributed in high traffic areas or through direct mail.

• Leaflets can contain important information about a product, service, event, or cause.

• They are visually appealing and can capture the attention of potential customers.

• Leaflets can be used to educate and inform the public about a particular topic or i...read more

A barcode is a machine-readable representation of data in a visual format on products or items.

• Barcodes are used for tracking inventory, pricing products, and speeding up the checkout process in retail stores.

• Common types of barcodes include UPC (Universal Product Code) and QR codes.

• Barcodes consist of parallel lines of varying widths and spaces that represent different numbers or characters.

• Barcodes can be scanned using barcode scanners or smartphone apps.

• Barcodes help impro...read more

Calibrations are an essential part of ensuring accuracy and reliability in technical systems.

• Calibrations involve comparing measurements of a device or instrument to a known standard.

• They are used to correct any deviations or inaccuracies in the measurements.

• Calibrations are performed regularly to maintain the quality and performance of equipment.

• Examples of calibrations include adjusting the temperature settings on an oven, calibrating a pressure gauge, or aligning the laser...read more

Standardization in KF is performed to ensure consistency and accuracy in measurements and results.

• Standardization helps in comparing results across different labs or studies.

• It reduces variability and improves reliability of the data.

• Standardization involves using known reference materials or methods to calibrate instruments or procedures.

• For example, in medical testing, standardization ensures that test results are accurate and comparable.

Aerobic bacteria require oxygen to grow and survive, while anaerobic bacteria do not.

• Aerobic bacteria need oxygen for their metabolism

• Anaerobic bacteria can survive in environments without oxygen

• Examples of aerobic bacteria include Mycobacterium tuberculosis, Escherichia coli

• Examples of anaerobic bacteria include Clostridium botulinum, Bacteroides fragilis

A smoke study is a test conducted to evaluate the airflow patterns within a cleanroom or controlled environment.

• Smoke is released into the environment to visualize the airflow patterns.

• The study helps identify areas of turbulence or dead spots where contaminants may accumulate.

• Results of the study can be used to optimize the layout of equipment and ventilation systems.

• Smoke studies are commonly used in pharmaceutical manufacturing, semiconductor production, and healthcare fac...read more

SOP full foam is a standard operating procedure for using full foam in a technical support role.

• SOP full foam is a step-by-step guide for using full foam in technical support tasks.

• It includes instructions on how to properly apply full foam, troubleshoot issues, and ensure safety.

• Examples of tasks covered in SOP full foam include cleaning computer components, insulating cables, and sealing gaps.

• Following SOP full foam helps ensure consistent and effective use of full foam in ...read more

Cleaning validation is the process of ensuring that cleaning procedures effectively remove residues from equipment used in production.

• Cleaning validation involves establishing documented evidence that cleaning procedures consistently remove residues to predetermined levels.

• It is important for ensuring product quality, preventing cross-contamination, and maintaining regulatory compliance.

• Validation typically includes sampling, testing, and documentation of cleaning processes.

• E...read more

QMS tools refer to software applications used to manage quality processes and documentation within an organization.

• QMS tools help streamline quality management processes

• Examples include ISOtrain, MasterControl, and TrackWise

• They often include features for document control, corrective actions, audits, and training management

GMP stands for Good Manufacturing Practices, while cGMP stands for Current Good Manufacturing Practices.

• GMP is a set of guidelines for ensuring products are consistently produced and controlled according to quality standards.

• cGMP is an updated version of GMP that includes current technologies and processes.

• cGMP is required by regulatory agencies like the FDA for pharmaceutical manufacturing.

• GMP is more general and can apply to various industries beyond pharmaceuticals.

21 CFR is a set of regulations issued by the FDA to ensure the quality, safety, and efficacy of medical products.

• 21 CFR stands for Title 21 of the Code of Federal Regulations

• It covers regulations related to food and drugs, including pharmaceuticals, medical devices, biologics, and cosmetics

• Compliance with 21 CFR is mandatory for companies seeking approval to market medical products in the US

Calibration of analytical instruments is essential to ensure accurate and reliable results.

• Regular calibration is necessary to maintain accuracy and precision of analytical instruments.

• Calibration involves comparing the measurements of the instrument to known standards.

• Adjustments are made to the instrument if discrepancies are found during calibration.

• Calibration records should be maintained for traceability and quality control purposes.

• Examples of analytical instruments tha...read more

KF and Potentiometer are used in analytical chemistry for titration and pH measurements.

• KF (Karl Fischer) is used for measuring moisture content in samples.

• Potentiometer is used for measuring pH levels in solutions.

• Both instruments are essential for accurate analysis in chemistry labs.

Validation is the process of ensuring that a product, service, or system meets the requirements and specifications set forth.

• Validation involves checking if a product meets the intended use requirements

• It ensures that the product is consistent with user needs and expectations

• Validation can include testing, inspection, and review processes

• Examples of validation include software testing to ensure it functions correctly and validation of medical devices to ensure they are safe a...read more

The number of handle machines varies depending on the specific engineering project or industry.

• The number of handle machines can range from one to multiple machines depending on the size and complexity of the project.

• For example, a small-scale engineering project may only require one handle machine, while a large-scale industrial project may require multiple handle machines for different tasks.

• It is important to assess the specific needs of the project to determine the approp...read more

Troubleshooting of HPLC involves identifying and resolving issues with the high-performance liquid chromatography system.

• Check for leaks in the system and tighten connections if necessary.

• Inspect the column for blockages or contamination and replace if needed.

• Calibrate the detector and ensure proper flow rate of the mobile phase.

• Troubleshoot error messages on the HPLC software by referring to the user manual.

• Consult with colleagues or technical support for assistance with com...read more

DNA is double-stranded, contains deoxyribose sugar, and thymine base. RNA is single-stranded, contains ribose sugar, and uracil base.

• DNA stands for deoxyribonucleic acid, while RNA stands for ribonucleic acid.

• DNA is double-stranded, while RNA is single-stranded.

• DNA contains the sugar deoxyribose, while RNA contains the sugar ribose.

• DNA contains the base thymine, while RNA contains the base uracil.

• DNA is more stable and less prone to mutations compared to RNA.

Calibration of HPLC involves adjusting the settings and parameters of the equipment to ensure accurate and reliable results.

• Calibration involves checking and adjusting the flow rate, detector sensitivity, and column efficiency.

• Regular calibration helps maintain the accuracy and precision of the HPLC system.

• Calibration standards are used to verify the performance of the HPLC system.

• Calibration should be performed before starting a new analysis or when there are changes in the ...read more