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80+ Gland Pharma Interview Questions and Answers

Updated 26 Jan 2025
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Q1. 2) what are tests performed for autoclave?

Ans.

Tests performed for autoclave include biological indicator testing, temperature mapping, and pressure testing.

  • Biological indicator testing is done to ensure that the autoclave is effectively killing microorganisms.

  • Temperature mapping is performed to ensure that the autoclave is maintaining the required temperature throughout the sterilization process.

  • Pressure testing is conducted to verify that the autoclave is maintaining the necessary pressure for sterilization.

  • Other tests ...read more

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Q2. If set values of parameters affects to the product quality then it is a direct impact ; if does not affect then called non impact

Ans.

The impact of set values of parameters on product quality

  • Set values of parameters can have a direct impact on product quality

  • If the set values do not affect the product quality, it is considered non-impactful

  • Examples of parameters that can affect product quality include temperature, pressure, and time

  • Proper calibration and monitoring of parameters can ensure consistent product quality

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Q3. 1) what are HVAC tests?

Ans.

HVAC tests are tests conducted to ensure the proper functioning and efficiency of heating, ventilation, and air conditioning systems.

  • HVAC tests involve checking the temperature control and distribution systems.

  • Tests may include measuring airflow, checking for leaks, and inspecting ductwork.

  • Performance tests are conducted to assess the overall efficiency and effectiveness of the HVAC system.

  • Examples of HVAC tests include air balance testing, refrigerant charge verification, an...read more

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Q4. 10) what are input logs and out put logs, where we use these?

Ans.

Input and output logs are records of data entering and leaving a system. They are used for troubleshooting and auditing purposes.

  • Input logs record data that enters a system, such as user input or data from another system.

  • Output logs record data that leaves a system, such as responses to user requests or data sent to another system.

  • These logs are used for troubleshooting issues with the system, as well as for auditing and compliance purposes.

  • Examples of systems that use input ...read more

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Q5. What are the tests performed for autoclave

Ans.

Autoclave tests ensure proper functioning and sterilization of equipment.

  • Biological indicator testing to ensure proper sterilization

  • Physical testing to ensure proper temperature and pressure

  • Chemical testing to ensure proper chemical indicators are met

  • Leak testing to ensure proper seal and prevent contamination

  • Cycle testing to ensure consistent performance over time

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Q6. What is the mean of Direct impact and No impact systems

Ans.

The mean of Direct impact and No impact systems is undefined.

  • Direct impact and No impact systems are not comparable in terms of impact.

  • Direct impact systems have a significant impact on the organization or process, while No impact systems have no impact.

  • Therefore, calculating the mean of these two types of systems is not meaningful.

  • It is important to evaluate the impact of each system separately and make decisions accordingly.

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Q7. how to the calibrate pressure gauges,vacuum gauges,compound gauges,

Ans.

To calibrate pressure gauges, vacuum gauges, and compound gauges, follow these steps:

  • Use a known reference pressure source to compare the readings of the gauges.

  • Adjust the gauges if there is any deviation from the reference pressure.

  • Repeat the process multiple times to ensure accuracy.

  • Document the calibration process and results for future reference.

  • Perform regular calibrations to maintain accuracy.

  • Example: For pressure gauges, connect them to a pressure calibrator and adjust...read more

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Q8. how to the calibration temperature indicators

Ans.

Calibrating temperature indicators involves adjusting them to ensure accurate readings.

  • Calibration of temperature indicators involves comparing their readings to a known standard.

  • Adjustments are made to the indicators to align their readings with the standard.

  • Calibration may involve adjusting the zero point and span of the indicators.

  • Examples of temperature indicators include thermometers, temperature sensors, and temperature gauges.

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Q9. 3) what are tests performed for tunnel?

Ans.

Tests performed for tunnel include connectivity, throughput, latency, and security.

  • Connectivity tests ensure that the tunnel is properly established and data can be transmitted.

  • Throughput tests measure the amount of data that can be transmitted through the tunnel in a given time period.

  • Latency tests measure the delay between data being sent and received through the tunnel.

  • Security tests ensure that the tunnel is secure and data cannot be intercepted or tampered with.

  • Examples ...read more

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Q10. What is your knowledge of injectable pharmaceuticals and the basic Good Manufacturing Practice (GMP) guidelines?

Ans.

I have a strong knowledge of injectable pharmaceuticals and GMP guidelines.

  • I am familiar with the manufacturing process of injectable pharmaceuticals, including sterile compounding and packaging.

  • I understand the importance of following GMP guidelines to ensure the quality and safety of pharmaceutical products.

  • I am aware of the regulations and standards set by regulatory bodies such as the FDA and EMA for manufacturing injectable pharmaceuticals.

  • I have experience in implementi...read more

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Q11. What are the tests performed for HVAC

Ans.

Tests performed for HVAC include airflow measurement, temperature measurement, pressure measurement, and refrigerant leak detection.

  • Airflow measurement: Testing the volume of air being circulated by the HVAC system using an anemometer.

  • Temperature measurement: Checking the temperature of the air at various points in the system using thermometers or temperature sensors.

  • Pressure measurement: Assessing the pressure levels within the HVAC system using pressure gauges.

  • Refrigerant l...read more

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Q12. What is line clearance. Define contamination and cross contamination. Define autoclave priciple and temperature. Define calibration and validation. What is data integrity. What is clean rooms.

Ans.

Line clearance, contamination, cross contamination, autoclave principle and temperature, calibration and validation, data integrity, and clean rooms are important concepts in pharmaceutical manufacturing.

  • Line clearance is the process of ensuring that equipment and work areas are free of any materials from previous operations.

  • Contamination is the presence of any harmful substance in a product or environment.

  • Cross contamination is the transfer of harmful substances from one pro...read more

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Q13. what is the calibration

Ans.

Calibration is the process of adjusting or verifying the accuracy of a measuring instrument or device.

  • Calibration ensures that measurements taken by an instrument are accurate and reliable.

  • It involves comparing the measurements of a device to a known standard.

  • Calibration may involve adjusting the device to bring it in line with the standard.

  • It is important in various fields like engineering, manufacturing, and scientific research.

  • For example, a thermometer may be calibrated b...read more

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Q14. 8) what is the speed(rpm) ratio for tunnel?

Ans.

The speed ratio for a tunnel depends on various factors such as the size and type of the tunnel.

  • The speed ratio for a tunnel can range from 10 to 100 rpm depending on the size and type of the tunnel.

  • The speed ratio is calculated by dividing the speed of the conveyor belt by the speed of the tunnel.

  • For example, if the conveyor belt is moving at a speed of 100 feet per minute and the tunnel is 10 feet long, the speed ratio would be 10 rpm.

  • The speed ratio is important for ensuri...read more

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Q15. 9) Different types of Gamp categorisation and what are they?

Ans.

GAMP categorisation refers to the different levels of software used in the pharmaceutical industry.

  • GAMP stands for Good Automated Manufacturing Practice

  • There are five categories of GAMP: Category 1, 2, 3, 4, and 5

  • Each category has different requirements for validation and documentation

  • Category 1 includes software that has no impact on product quality

  • Category 5 includes software that has a direct impact on product quality

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Q16. 7) what is F°= value in autoclave?

Ans.

F°= value in autoclave refers to the temperature at which sterilization is carried out.

  • F°= value is the temperature at which autoclave sterilizes the equipment.

  • It is usually set at 121°C for 15 minutes for most applications.

  • The F°= value ensures that all microorganisms are killed during the sterilization process.

  • It is important to monitor and validate the F°= value to ensure proper sterilization.

  • Different F°= values may be required for different types of equipment or material...read more

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Q17. What is hplc and what is used for detector calibration?

Ans.

HPLC is a technique used in chemistry to separate, identify, and quantify components in a mixture. Detector calibration ensures accurate measurement.

  • HPLC stands for High-Performance Liquid Chromatography.

  • It is used to separate and analyze components in a liquid mixture.

  • HPLC utilizes a stationary phase and a mobile phase to separate the components based on their interactions.

  • The detector in HPLC measures the concentration of the separated components.

  • Detector calibration involv...read more

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Q18. how to checking the door inter lock systems

Ans.

To check door interlock systems, inspect the physical components, test the electrical connections, and verify proper functioning.

  • Inspect the door hinges, latches, and locks for any damage or misalignment.

  • Check the wiring connections and ensure they are secure and not damaged.

  • Test the interlock switch by opening and closing the door to see if it activates properly.

  • Verify that the interlock system prevents the door from being opened when the machine is in operation.

  • Ensure that ...read more

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Q19. Are you interested in Microbiology analytical review?

Ans.

Yes, I am interested in Microbiology analytical review.

  • I have a strong background in microbiology and enjoy analyzing data in this field.

  • I have experience conducting microbiological tests and interpreting the results.

  • I am familiar with various microbiological techniques and methodologies.

  • I am interested in staying updated with the latest advancements in microbiology research.

  • I believe that my knowledge and skills in microbiology will contribute to my role as a Quality Assuran...read more

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Q20. Critical parameters of filling and batch manufacturing, lineclearance for dispensing, batch manufacturing, filling.

Ans.

Critical parameters for filling and batch manufacturing include line clearance for dispensing and filling.

  • Filling parameters include volume, weight, and viscosity of the product.

  • Batch manufacturing parameters include mixing time, temperature, and pressure.

  • Line clearance for dispensing and filling involves cleaning and sanitizing the equipment and work area.

  • Proper documentation and record keeping are essential for ensuring compliance with regulations.

  • Examples of critical param...read more

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Q21. Tell me about change Control? And give me One Example?

Ans.

Change control is a process used to manage and document changes to a system or process.

  • Change control ensures that changes are properly reviewed, approved, and implemented.

  • It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

  • Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing the change, and reviewing its effectiveness.

  • An example of...read more

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Q22. 6) Define span, spread and equilibrium time?

Ans.

Explanation of span, spread and equilibrium time.

  • Span refers to the duration of time over which a process or event occurs.

  • Spread refers to the distribution of values or results within a given set of data.

  • Equilibrium time is the time required for a system to reach a steady state or balance.

  • For example, the span of a clinical trial may be several years, the spread of test results may vary widely, and the equilibrium time for a chemical reaction may be minutes or hours.

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Q23. What is genotoxic impurities and how we can control in the process

Ans.

Genotoxic impurities are substances that have the potential to cause DNA damage and mutations.

  • Genotoxic impurities can be present in raw materials, intermediates, or final products.

  • They can be controlled by implementing appropriate measures such as using high-quality raw materials, optimizing the manufacturing process, and conducting thorough testing.

  • Examples of genotoxic impurities include nitrosamines, polycyclic aromatic hydrocarbons, and heavy metals.

  • Regulatory agencies s...read more

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Q24. What are the tests performed for tunnel

Ans.

Tests performed for tunnel

  • Permeability test

  • Water pressure test

  • Load test

  • Visual inspection

  • Geotechnical investigation

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Q25. What is the purpose Risk assessment?

Ans.

Risk assessment is the process of identifying, analyzing and evaluating potential risks to an organization or project.

  • Helps in identifying potential risks and their impact

  • Enables prioritization of risks based on their severity

  • Assists in developing strategies to mitigate or manage risks

  • Provides a framework for decision-making and resource allocation

  • Examples: financial risk assessment, cybersecurity risk assessment, project risk assessment

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Q26. 5) Flow of automation (CSV validation)?

Ans.

Automation flow for CSV validation involves identifying data sources, creating test cases, executing tests, and generating reports.

  • Identify data sources and ensure data integrity

  • Create test cases based on requirements and expected outcomes

  • Execute tests using automation tools and scripts

  • Validate results and identify any discrepancies

  • Generate reports to document test results and findings

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Q27. how to the calibration of rtds

Ans.

Calibration of RTDs involves comparing the sensor's output to a known reference and adjusting it accordingly.

  • RTDs (Resistance Temperature Detectors) are calibrated to ensure accurate temperature measurements.

  • Calibration involves comparing the RTD's resistance values at different temperatures to a known reference.

  • Adjustments are made to the RTD's output signal to align it with the reference values.

  • Calibration can be done using a calibration bath, dry block calibrator, or a tem...read more

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Q28. 4) Flow of equipment Qualifications?

Ans.

Equipment qualifications follow a defined flow to ensure compliance with regulations and standards.

  • The first step is to define the equipment and its intended use.

  • Next, the equipment is installed and tested to ensure it meets specifications.

  • Operational qualifications are then performed to ensure the equipment functions correctly.

  • Performance qualifications are conducted to ensure the equipment consistently produces accurate and reliable results.

  • Finally, maintenance and calibrat...read more

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Q29. how many types of flow meters

Ans.

There are several types of flow meters used in various industries to measure the flow rate of fluids or gases.

  • Some common types of flow meters include electromagnetic flow meters, ultrasonic flow meters, turbine flow meters, and positive displacement flow meters.

  • Electromagnetic flow meters use Faraday's law of electromagnetic induction to measure the flow rate of conductive fluids.

  • Ultrasonic flow meters utilize ultrasonic waves to measure the velocity of the fluid and calcula...read more

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Q30. What kind of clean rooms maintained in Sterile area

Ans.

Clean rooms in sterile areas are maintained to prevent contamination and ensure product safety.

  • Clean rooms are classified based on the number of particles per cubic meter of air.

  • Sterile areas typically have clean rooms classified as ISO 5 or ISO 7.

  • Clean rooms have controlled air flow, temperature, and humidity.

  • Personnel entering clean rooms must wear appropriate protective clothing.

  • Equipment and materials used in clean rooms must be sterilized or sanitized.

  • Examples of sterile...read more

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Q31. Flows of Validation

Ans.

Flows of Validation refers to the process of verifying and confirming the accuracy and integrity of data or information.

  • Flows of Validation involve checking data for errors, inconsistencies, and completeness.

  • Validation can be done through various methods such as data sampling, cross-referencing, and data reconciliation.

  • Examples of validation processes include validating financial transactions, validating user input in software applications, and validating scientific research ...read more

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Q32. What is the procedure for calibrating the RPM indicator?

Ans.

The procedure for calibrating the RPM indicator involves adjusting the settings to ensure accurate readings.

  • Ensure the RPM indicator is connected to a stable power source.

  • Use a known standard RPM value to compare the indicator readings.

  • Adjust the calibration settings on the indicator until it matches the standard value.

  • Repeat the process if necessary to achieve accurate calibration.

  • Document the calibration process for future reference.

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Q33. What is CAPA ,and OOS

Ans.

CAPA stands for Corrective and Preventive Action, while OOS stands for Out of Specification.

  • CAPA is a process used to identify, investigate, and resolve quality issues.

  • OOS refers to a result that falls outside of predetermined specifications.

  • CAPA and OOS are both important in maintaining quality control in various industries.

  • In the medical field, CAPA and OOS are crucial for ensuring patient safety and regulatory compliance.

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Q34. what are the ypes of Process validation?

Ans.

Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.

  • There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

  • Prospective validation is conducted before the process is put into routine use.

  • Concurrent validation is performed during routine production.

  • Retrospective validation involves reviewing historical data to pr...read more

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Q35. Tell me about in process control

Ans.

In process control is a system of checks and measures to ensure quality and consistency during the manufacturing process.

  • In process control involves monitoring and adjusting variables such as temperature, pressure, and pH levels to maintain quality standards.

  • It includes sampling and testing of raw materials, intermediates, and finished products to ensure they meet specifications.

  • Examples of in process control techniques include statistical process control, process capability ...read more

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Q36. In sterile EU GMP, grade a grade b grade c grade d rooms are there

Ans.

Yes, sterile EU GMP guidelines define four grades of cleanrooms: A, B, C, and D.

  • Sterile EU GMP guidelines define four grades of cleanrooms: A, B, C, and D.

  • Grade A is the most stringent and is used for critical operations such as aseptic filling.

  • Grade D is the least stringent and is used for activities such as gowning and material transfer.

  • Each grade has specific requirements for air cleanliness, particle counts, and microbial counts.

  • The classification of a cleanroom is determ...read more

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Q37. What is hplc and polar and nonpolar

Ans.

HPLC is a technique used in analytical chemistry to separate, identify, and quantify components in a mixture. Polar and nonpolar refer to the polarity of molecules.

  • HPLC stands for High-Performance Liquid Chromatography.

  • It is a widely used technique in pharmaceutical, chemical, and food industries.

  • HPLC separates components in a mixture based on their interactions with a stationary phase and a mobile phase.

  • The stationary phase is a solid or liquid material packed into a column,...read more

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Q38. What type of filler material is used in brazing

Ans.

The filler material used in brazing is typically a metal alloy that has a lower melting point than the materials being joined.

  • Filler materials in brazing are often composed of metals such as silver, copper, or nickel.

  • These filler materials are chosen based on their compatibility with the base metals being brazed.

  • The filler material is heated to its melting point and then flows into the joint, forming a strong bond when it solidifies.

  • Examples of filler materials used in brazin...read more

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Q39. How many test parameters in API product

Ans.

The number of test parameters in an API product can vary depending on the complexity and functionality of the product.

  • The number of test parameters in an API product is determined by the different inputs, outputs, and functionalities that need to be tested.

  • Common test parameters in API products include authentication, request parameters, response codes, error handling, and performance metrics.

  • The number of test parameters can range from a few dozen to hundreds, depending on t...read more

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Q40. Could you explain the schematic flow of a purified water system?

Ans.

A purified water system typically consists of multiple stages to remove impurities and ensure water quality.

  • The water first goes through a pre-treatment stage to remove large particles and debris.

  • Next, the water is passed through a series of filters to remove smaller particles and impurities.

  • After filtration, the water may undergo processes such as reverse osmosis or distillation to further purify it.

  • Finally, the purified water is stored in a tank or distributed directly for ...read more

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Q41. How to qualify washing And De pyrozanation tunnel

Ans.

Qualifying a washing and depyrogenation tunnel involves testing and validating its performance to ensure it meets regulatory requirements.

  • Performing validation tests to ensure the tunnel effectively removes contaminants and pyrogens

  • Conducting temperature mapping studies to verify uniformity throughout the tunnel

  • Testing the sterilization process to ensure it meets specified parameters

  • Documenting all validation activities and results for regulatory compliance

  • Regularly monitorin...read more

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Q42. Method's for managing different project's

Ans.

Different projects require different management methods. Here are some pointers.

  • Identify the project's goals and objectives

  • Create a project plan and timeline

  • Assign tasks and responsibilities to team members

  • Monitor progress and adjust plans as needed

  • Communicate regularly with stakeholders

  • Use project management software to track tasks and deadlines

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Q43. How you are doing Audit trail?

Ans.

Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.

  • Audit trail is created by recording all actions, events, and transactions that occur within a system.

  • It helps in ensuring accountability, traceability, and compliance with regulations.

  • Audit trail can be established through the use of logs, timestamps, and version control.

  • It is important to capture relevant information such as user IDs, timestamps, and descriptions of a...read more

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Q44. Do you know about Pharma industry and Production manufacturing

Ans.

Yes, I am familiar with the Pharma industry and Production manufacturing.

  • I have knowledge of Good Manufacturing Practices (GMP) and Quality Control (QC) procedures.

  • I am aware of the various stages of drug development, from research and development to clinical trials and commercial production.

  • I understand the importance of regulatory compliance and adherence to safety protocols.

  • I have experience working in a pharmaceutical manufacturing environment, including operating and mai...read more

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Q45. Tell me about ich guidelines?

Ans.

ICH guidelines are a set of internationally recognized standards for the development, registration, and post-approval of pharmaceutical products.

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

  • ICH guidelines provide recommendations on various aspects of drug development, including quality, safety, efficacy, and multidisciplinary topics.

  • Examples of ICH guidelines include Q1-Q14 guidelines, which cover topics su...read more

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Q46. Which solder is used tovaluminium

Ans.

The solder used to join aluminium is typically an aluminium-based solder.

  • Aluminium-based solder is commonly used for joining aluminium parts.

  • Aluminium solder typically contains a combination of aluminium and other metals such as zinc, tin, or copper.

  • The choice of solder depends on the specific application and the desired strength and durability of the joint.

  • Examples of aluminium-based solders include Alumiweld, Alumifix, and Alumi-Solder.

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Q47. Regulatory Guidelines applicable for QMS?

Ans.

Regulatory guidelines are essential for ensuring compliance with QMS standards.

  • ISO 9001:2015 is the most widely recognized QMS standard

  • FDA regulations apply to medical device manufacturers

  • EU MDR 2017/745 is the new regulation for medical devices in the European Union

  • Regulatory guidelines provide a framework for implementing and maintaining QMS

  • Non-compliance with regulatory guidelines can result in fines, legal action, and damage to reputation

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Q48. USP chapters of Microbial tesing of API and water

Ans.

The USP chapters related to microbial testing of API and water.

  • USP chapter <61> describes microbial enumeration tests for nonsterile products.

  • USP chapter <62> describes tests for specified microorganisms in nonsterile products.

  • USP chapter <1231> describes water for pharmaceutical purposes and includes microbial enumeration tests.

  • USP chapter <1232> describes the testing of pharmaceutical water for specified microorganisms.

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Q49. What is the asceptic operations in clean room

Ans.

Aseptic operations in clean room refer to the procedures and techniques used to maintain a sterile environment during production.

  • Strict adherence to hygiene protocols

  • Use of sterile equipment and materials

  • Regular cleaning and disinfection of surfaces and equipment

  • Proper gowning and personal protective equipment (PPE)

  • Air filtration and control of environmental factors

  • Examples include pharmaceutical manufacturing, medical device production, and food processing

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Q50. Basic aspects and formulation details of Parenterals ,lyophilization, HPLC,

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Q51. What is the main sensor of autovlave

Ans.

The main sensor of an autoclave is a pressure sensor.

  • The pressure sensor monitors the pressure inside the autoclave to ensure it reaches the desired level for sterilization.

  • It helps in regulating the temperature and pressure during the sterilization process.

  • Common types of pressure sensors used in autoclaves include strain gauge pressure sensors and piezoelectric pressure sensors.

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Q52. Difference between method validation and method development

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Q53. Tools used in program management

Ans.

Tools used in program management include Gantt charts, project management software, and risk management tools.

  • Gantt charts help visualize project timelines and dependencies

  • Project management software like Asana or Trello can help with task assignment and tracking

  • Risk management tools like SWOT analysis or FMEA can help identify and mitigate potential issues

  • Communication tools like Slack or Microsoft Teams can help keep team members connected and informed

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Q54. Critical alarms of autoclave and their importance

Ans.

Critical alarms of autoclave are important for safety and proper functioning.

  • Low water level alarm to prevent overheating and damage to equipment

  • High pressure alarm to prevent explosion or damage to equipment

  • Door lock alarm to prevent accidental opening during operation

  • Temperature alarm to ensure proper sterilization

  • Cycle completion alarm to indicate the end of the sterilization process

  • Regular maintenance and calibration of alarms is necessary for accuracy and reliability

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Q55. Process vlaidation batches importance and role

Ans.

Process validation batches are crucial for ensuring product quality and consistency.

  • Process validation batches help to establish that a manufacturing process is capable of consistently producing a product that meets predetermined specifications.

  • They are important for ensuring product quality and consistency, as well as for regulatory compliance.

  • Validation batches should be representative of routine production batches and should be thoroughly documented and analyzed.

  • Examples o...read more

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Q56. Examples for the Change Controls?

Ans.

Change controls are procedures used to manage changes to a system or process.

  • Documenting the change request

  • Assessing the impact of the change

  • Obtaining approval for the change

  • Implementing the change

  • Testing the change

  • Reviewing and closing the change request

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Q57. How many types of Deviation s?

Ans.

There are two main types of deviations: positive deviations and negative deviations.

  • Positive deviations occur when actual results exceed expected results.

  • Negative deviations occur when actual results fall short of expected results.

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Q58. What is line clearance

Ans.

Line clearance is a process of ensuring that equipment and work areas are free from any previous product or material before starting a new process.

  • It involves a visual inspection of the equipment and work area to ensure cleanliness and absence of any residual material.

  • It is important to prevent cross-contamination and ensure product quality.

  • Examples include cleaning of manufacturing equipment, changeover of packaging materials, and transfer of materials between different area...read more

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Q59. Bottleneck management of project

Ans.

Bottleneck management involves identifying and resolving issues that slow down project progress.

  • Identify the bottleneck by analyzing the project flow

  • Prioritize the bottleneck based on its impact on the project timeline

  • Develop a plan to resolve the bottleneck

  • Implement the plan and monitor progress

  • Communicate with stakeholders about the bottleneck and its resolution

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Q60. Process flow of programs management

Ans.

Programs management involves planning, executing, monitoring, and controlling the processes of a project.

  • Identify project goals and objectives

  • Develop a project plan

  • Assign tasks and responsibilities

  • Monitor progress and make adjustments

  • Evaluate project success and identify areas for improvement

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Q61. Purified water specification of Microbal

Ans.

The purified water specification for microbial quality assurance.

  • Microbial specification for purified water is crucial to ensure its safety and suitability for use.

  • The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

  • Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

  • The specification may vary depending on the intended use of the purified wa...read more

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Q62. What is the unitvof resistivity

Ans.

The unit of resistivity is ohm-meter (Ω·m).

  • Resistivity is a measure of a material's ability to resist the flow of electric current.

  • It is the intrinsic property of a material and is independent of its shape or size.

  • Resistivity is denoted by the symbol ρ (rho).

  • It is calculated by dividing the resistance of a material by its cross-sectional area and length.

  • Common examples of resistivity values: copper - 1.68 × 10^-8 Ω·m, aluminum - 2.65 × 10^-8 Ω·m, rubber - 1 × 10^13 Ω·m.

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Q63. What is suspension

Ans.

Suspension is a mixture in which solid particles are dispersed in a liquid or gas, forming a heterogeneous system.

  • Suspension is a type of colloid, where the solid particles are larger and do not dissolve in the liquid or gas.

  • The solid particles in a suspension can settle over time due to gravity, forming a sediment at the bottom.

  • Examples of suspensions include muddy water, orange juice with pulp, and paint.

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Q64. What is the deviation ?

Ans.

Deviation is the amount by which a single measurement differs from a fixed value or average.

  • Deviation is a measure of how spread out the values in a data set are.

  • It is calculated by finding the difference between each data point and the mean of the data set.

  • Positive deviations indicate values above the mean, while negative deviations indicate values below the mean.

  • Deviation is commonly used in statistics to analyze the variability of data.

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Q65. Purified water specification?

Ans.

Purified water specification refers to the set of requirements and standards that purified water must meet.

  • Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

  • It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

  • The pH level of purified water should be within a specific range, typically between 5.0 and 7.0.

  • It should be free from any taste, ...read more

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Q66. What is tablet

Ans.

A tablet is a portable computing device with a touchscreen display, designed for mobile use.

  • Tablets are typically larger than smartphones but smaller than laptops.

  • They are used for browsing the internet, watching videos, playing games, and running apps.

  • Examples of popular tablets include the iPad, Samsung Galaxy Tab, and Amazon Fire HD.

  • Tablets can also be used for productivity tasks such as word processing and email.

  • Some tablets come with a stylus for drawing or taking notes.

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Q67. Daily work explanations

Ans.

Daily work explanations involve providing detailed descriptions of tasks and activities performed on a daily basis.

  • Start by outlining the main tasks and responsibilities for the day

  • Provide specific examples of projects worked on or meetings attended

  • Explain any challenges faced and how they were overcome

  • Discuss any collaborations with team members or supervisors

  • Summarize the overall impact of daily work on achieving goals

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Q68. Disintegration and dissolution difference

Ans.

Disintegration is the breakdown of a solid dosage form into smaller particles, while dissolution is the process by which a solid substance dissolves in a liquid.

  • Disintegration is a physical process, while dissolution is a chemical process.

  • Disintegration involves the breaking down of a tablet or capsule into smaller pieces, while dissolution involves the solubilization of the active ingredient.

  • Disintegration testing is typically done using a disintegration tester, while dissol...read more

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Q69. What is regulatory bodies

Ans.

Regulatory bodies are organizations that enforce laws and regulations to ensure compliance and safety in various industries.

  • Regulatory bodies set standards and guidelines for companies to follow

  • They monitor and inspect businesses to ensure compliance with regulations

  • Examples include FDA in the pharmaceutical industry and EPA in the environmental sector

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Q70. Role of patent in biopharmaceutical

Ans.

Patents play a crucial role in protecting the intellectual property of biopharmaceutical companies.

  • Patents provide legal protection for the unique processes, methods, and products developed by biopharmaceutical companies.

  • They allow companies to recoup their investment in research and development by preventing competitors from copying their innovations.

  • Patents also encourage innovation by providing an incentive for companies to invest in research and development.

  • Without patent...read more

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Q71. What kind balance used

Ans.

Various types of balances are used in warehouse operations to ensure accurate measurements of goods.

  • Different types of balances such as platform scales, floor scales, and counting scales are commonly used in warehouses.

  • Balances are used to weigh incoming and outgoing goods, ensuring accurate inventory management.

  • Regular calibration and maintenance of balances are essential to ensure accurate measurements.

  • Digital balances are becoming more popular due to their precision and ea...read more

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Q72. What is ingection

Ans.

Injection is a method of introducing a substance into the body using a needle and syringe.

  • Injections can be used for medical purposes such as administering vaccines or medication.

  • They can also be used for cosmetic purposes such as injecting fillers or Botox.

  • There are different types of injections including intramuscular, subcutaneous, and intravenous.

  • Injections should always be administered by a trained professional to avoid complications.

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Q73. What is sterilization

Ans.

Sterilization is the process of killing all microorganisms, including bacteria, viruses, fungi, and spores, to prevent contamination.

  • Sterilization can be achieved through various methods such as heat, chemicals, radiation, and filtration.

  • Common examples of sterilization methods include autoclaving, ethylene oxide gas sterilization, and UV light sterilization.

  • Sterilization is crucial in medical settings to prevent the spread of infections and ensure patient safety.

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Q74. Operation of PWG,PSG,MCDW,PRG,PLANTS

Ans.

PWG, PSG, MCDW, PRG, and PLANTS are all related to the operation of utility systems.

  • PWG stands for Power Generating Unit and is responsible for generating electricity.

  • PSG stands for Power Substation Generator and is responsible for distributing electricity.

  • MCDW stands for Municipal Cold Drinking Water and is responsible for providing clean drinking water.

  • PRG stands for Pressure Reducing Station and is responsible for regulating water pressure.

  • PLANTS refer to various utility p...read more

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Q75. types of validation

Ans.

Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.

  • Functional Validation: Ensuring that the system meets the functional requirements.

  • Performance Validation: Verifying that the system performs as expected under different load conditions.

  • Security Validation: Checking the system for vulnerabilities and ensuring data protection.

  • Usability Validation: Assessing the us...read more

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Q76. What is type A cleaning

Ans.

Type A cleaning refers to a thorough cleaning process that involves removing all visible dirt and debris from a surface.

  • Type A cleaning involves cleaning surfaces to a visibly clean state

  • It typically includes dusting, wiping, and scrubbing to remove dirt and debris

  • Type A cleaning is often required in industries like food production and pharmaceuticals to maintain cleanliness standards

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Q77. What is type B cleaning

Ans.

Type B cleaning is a cleaning process that involves the removal of visible dirt and debris from surfaces.

  • Type B cleaning is a basic level of cleaning that focuses on removing visible contaminants from surfaces.

  • It does not involve disinfection or sterilization.

  • Examples of Type B cleaning include sweeping, dusting, and wiping down surfaces with a damp cloth.

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Q78. what is Pharmacology

Ans.

Pharmacology is the study of how drugs interact with living organisms and how they affect the body.

  • Pharmacology involves studying the properties, effects, and uses of drugs.

  • It explores how drugs are absorbed, distributed, metabolized, and excreted by the body.

  • Pharmacologists research the mechanisms of drug action and develop new medications.

  • They also investigate drug interactions, side effects, and potential toxicity.

  • Examples of pharmacology include studying the effects of an...read more

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Q79. What are clean rooms

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Q80. Schedule m guidelines

Ans.

Schedule M guidelines are regulations set by the Drugs and Cosmetics Act in India for the manufacturing of drugs.

  • Schedule M guidelines ensure the quality and safety of pharmaceutical products.

  • They cover aspects such as premises, equipment, personnel, documentation, and quality control.

  • Adherence to Schedule M guidelines is mandatory for pharmaceutical manufacturers in India.

  • Non-compliance can lead to penalties or suspension of manufacturing licenses.

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Q81. Pics guidelines

Ans.

Pics guidelines refer to the rules and regulations for posting images on social media platforms.

  • Pics guidelines are important for maintaining a professional image online.

  • They often include rules about image quality, content, and copyright.

  • Examples of pics guidelines may include not posting inappropriate images, ensuring images are clear and relevant, and obtaining permission before using someone else's image.

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Q82. Define the principle of tlc

Ans.

TLC stands for Thin Layer Chromatography, a technique used to separate and analyze mixtures of chemicals.

  • TLC involves a stationary phase (thin layer of adsorbent material) and a mobile phase (solvent).

  • The sample mixture is spotted on the TLC plate and the plate is placed in a developing chamber with the mobile phase.

  • Different components of the mixture move at different rates on the plate, allowing for separation and identification.

  • Rf value (retention factor) is used to calcul...read more

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