100+ Aker Solutions Interview Questions and Answers

UV-Visible Spectroscopy is based on the interaction between light and matter resulting in the production of distinct spectra.

• UV-Visible Spectroscopy is a non-destructive technique used to determine the concentration of a sample.

• It is widely used in the pharmaceutical industry to analyze drug compounds.

• The spectra produced can be used to identify unknown compounds and monitor chemical reactions.

• UV-Visible Spectroscopy is also used in environmental analysis to measure pollutant...read more

We have 10 compression machines in our company.

• We have a total of 10 compression machines.

• These machines are used for compressing various materials.

• They are an essential part of our production process.

• The machines are regularly maintained to ensure optimal performance.

• Examples of materials that are compressed include plastics, metals, and powders.

I have a comprehensive understanding of the market, including size, competitors, and leading geographies.

• I have conducted market research to determine the size of the market and identify key trends.

• I am aware of the number of competitors in the market and their strengths and weaknesses.

• I have analyzed market data to identify leading geographies where our product/service has the most potential for growth.

Biohazards can include infectious waste, sharps, and biological agents. Disposal methods vary depending on the type of biohazard.

• Infectious waste should be treated and disposed of according to local regulations

• Sharps should be placed in puncture-resistant containers and disposed of through a licensed medical waste disposal company

• Biological agents may require specialized disposal methods, such as incineration or autoclaving

• Training and education for employees on proper handli...read more

Blister packaging is a type of packaging where the product is placed in a pre-formed plastic cavity. Printing techniques, types of boards, vendor development, and changepart development are all related to the design and production of packaging.

• Blister packaging involves a pre-formed plastic cavity that holds the product

• Printing techniques refer to the methods used to print information on the packaging

• Types of boards refer to the materials used to create the packaging, such as...read more

Granulation is a process of forming granules from powder. There are two types of granulation - wet and dry. Various machines are used for granulation.

• Wet granulation involves adding a liquid binder to the powder mixture to form granules. Dry granulation involves compacting the powder mixture to form granules.

• Some machines used for wet granulation are high shear mixers, fluid bed granulators, and rotary granulators. Some machines used for dry granulation are roller compactors ...read more

Load cell calibration procedure involves testing and adjusting the load cell to ensure accurate measurement.

• Verify the load cell specifications and calibration requirements

• Apply known loads to the load cell and record readings

• Compare the readings with the expected values and adjust if necessary

• Repeat the process until the load cell readings are within the acceptable range

• Document the calibration process and results

LOQ stands for Limit of Quantitation as per ICH guidelines. It is the lowest concentration of an analyte that can be reliably measured.

• LOQ is determined by analyzing a series of samples with known concentrations of the analyte and calculating the standard deviation and slope of the calibration curve.

• The LOQ is typically defined as the concentration at which the signal-to-noise ratio is at least 10:1.

• It is important to establish the LOQ for a method to ensure accurate and prec...read more

There is no disadvantage of organic chemistry, only challenges to overcome.

• Organic chemistry is essential for the development of new drugs and materials.

• It can be challenging to synthesize complex organic molecules.

• Organic compounds can be volatile and hazardous to work with.

• However, proper safety measures can mitigate these risks.

• Overall, organic chemistry is a valuable and necessary field of study.

MLSS stands for Mixed Liquor Suspended Solids.

• MLSS refers to the concentration of suspended solids in a mixed liquor sample.

• It is an important parameter in wastewater treatment processes.

• MLSS is measured in milligrams per liter (mg/L) or parts per million (ppm).

• It indicates the biological activity and treatment efficiency of the system.

• Maintaining optimal MLSS levels is crucial for effective wastewater treatment.

Fire water capacity can be calculated based on the fire hazard classification and the size of the facility.

• Determine the fire hazard classification of the facility

• Calculate the required fire flow rate based on the classification

• Determine the duration of the fire event

• Multiply the fire flow rate by the duration to get the fire water capacity

• Consider any additional factors such as fire department response time and water supply availability

Specificity in assay method refers to the ability of the method to accurately measure only the target analyte without interference from other substances.

• Specificity is determined by testing the method with known standards and samples containing the target analyte as well as potential interfering substances.

• Cross-reactivity with similar compounds should be evaluated to ensure the method is specific to the target analyte.

• Selectivity is another term used interchangeably with spe...read more

To minimize hazardous waste, we implement measures such as waste reduction, recycling, and proper disposal.

• We conduct waste audits to identify areas where waste can be reduced.

• We implement a waste reduction program that includes reducing the use of hazardous materials.

• We recycle materials such as paper, plastic, and metal.

• We properly dispose of hazardous waste by following regulations and using licensed disposal facilities.

• We train employees on proper waste management practic...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data integrity ensures that data remains unchanged and reliable.

• It involves maintaining the accuracy and consistency of data over time.

• Data integrity can be achieved through various methods such as validation, encryption, and backup.

• Examples of data integrity issues include data corruption, unauthorized modifications, and data loss.

• Ensuring data integrity is crucial in industr...read more

A medical representative is responsible for promoting and selling medical products to healthcare professionals.

• Promoting and selling medical products to healthcare professionals

• Building and maintaining relationships with healthcare professionals

• Providing product information and education to healthcare professionals

• Attending conferences and meetings to network and promote products

• Monitoring market trends and competitor activities

• Achieving sales targets and objectives

• Collecting...read more

System suitability parameters for HPLC ensure the proper functioning of the system and accuracy of results.

• Retention time of the analyte

• Resolution between peaks

• Theoretical plates

• Peak symmetry factor

• Limit of detection and quantification

• Accuracy and precision of the system

• Mobile phase composition and pH

• Column temperature and pressure

• Flow rate and injection volume

Pharmacokinetics is the study of how drugs move through the body, while pharmacodynamics is the study of how drugs interact with the body.

• Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of drugs in the body.

• Pharmacodynamics involves the study of how drugs interact with receptors and enzymes in the body to produce a therapeutic effect.

• Understanding pharmacokinetics and pharmacodynamics is important for determining the appropriate dose and dosi...read more

Equipment cleaning procedure involves thorough cleaning and sanitization to prevent contamination. MACO is calculated based on the maximum allowable carryover of a product.

• Equipment cleaning should follow a detailed procedure outlined in the standard operating procedures (SOPs)

• Different types of cleaning agents may be used based on the equipment and the substances it comes in contact with

• MACO calculation involves determining the maximum allowable carryover of a product on the...read more

Thermodynamics is the study of energy and its transformations. It involves laws like the first and second laws of thermodynamics.

• Thermodynamics is the branch of physics that deals with the relationships between heat, work, and energy.

• The first law of thermodynamics, also known as the law of energy conservation, states that energy cannot be created or destroyed, only transferred or transformed.

• The second law of thermodynamics states that the entropy of an isolated system alway...read more

Preventive maintenance is proactive maintenance performed to prevent equipment failure, while planned maintenance is scheduled maintenance to ensure optimal performance.

• Preventive maintenance involves regularly inspecting, cleaning, and servicing equipment to prevent breakdowns and extend its lifespan.

• Planned maintenance is scheduled in advance and includes tasks like replacing worn-out parts, lubricating machinery, and calibrating instruments.

• Preventive maintenance aims to i...read more

The question asks for a reaction and prediction of H1 NMR under different conditions.

• Provide a detailed reaction involving a compound and reagent

• Discuss the possible H1 NMR shifts based on the reaction conditions

• Consider variations in temperature, solvent, and concentration for different predictions

Load cells are available in various parts of the machine.

• Load cells are commonly found in the weighing system of the machine.

• They can also be found in the material handling system to measure the weight of the material being moved.

• Load cells may be present in the machine's hydraulic or pneumatic systems to measure force or pressure.

• They can also be used in the machine's safety systems to detect overloading or excessive force.

• Load cells may be located in the machine's control p...read more

Gun validation procedure is a process to ensure that a firearm is safe and functional.

• The gun is visually inspected for any damage or defects.

• The gun is disassembled and inspected for any wear or damage to internal parts.

• The gun is test fired to ensure that it functions properly.

• The gun's serial number is checked against a database to ensure that it is not stolen.

• The gun is marked with a unique identifier to indicate that it has been validated.

• The validation procedure may var...read more

Packaging products in pharmaceutical industry include bottles, blister packs, vials, ampoules, and sachets.

• Bottles

• Blister packs

• Vials

• Ampoules

• Sachets

Relative humidity (RH) is the amount of water vapor present in air compared to the maximum amount that could be held at that temperature, while absolute humidity is the actual amount of water vapor present in the air.

• Relative humidity is expressed as a percentage, while absolute humidity is expressed in grams of water vapor per cubic meter of air.

• Relative humidity changes with temperature, while absolute humidity remains constant.

• Relative humidity is used to determine comfort...read more

Condensate water is generated in a boiler when steam is condensed back into water.

• Condensate water is a byproduct of the steam generation process in a boiler

• It is generated when steam is cooled and condensed back into water

• This water is typically high in purity and can be reused in the boiler or for other purposes

• Methods for generating condensate water include using heat exchangers or cooling towers

End point in granulation refers to the point where the desired granule size is achieved.

• End point is determined by monitoring the granule size distribution.

• In RMG, the end point is usually achieved when the desired particle size is obtained and the moisture content is within the specified range.

• In FBD, the end point is reached when the desired particle size is achieved and the moisture content is within the specified range.

• The end point can also be determined by assessing the...read more

Degradation studies are essential to understand the stability and shelf-life of pharmaceutical products.

• To determine the degradation pathways of a drug substance or product

• To establish the shelf-life of a pharmaceutical product

• To ensure the safety and efficacy of the product over time

• To comply with regulatory requirements

• To optimize storage conditions for the product

• Examples: conducting stress testing, accelerated stability studies, photostability testing

There are four types of fire: Class A, Class B, Class C, and Class D. Each type requires a specific type of fire extinguisher.

• Class A fires involve ordinary combustibles such as wood, paper, or cloth. Water or foam extinguishers are suitable for this type of fire.

• Class B fires involve flammable liquids such as gasoline or oil. Carbon dioxide or dry chemical extinguishers are suitable for this type of fire.

• Class C fires involve electrical equipment such as appliances or wiring...read more

DMF stands for Drug Master File, which contains information about the manufacturing, processing, and packaging of a drug.

• DMF is a submission made to regulatory authorities to provide confidential information about the drug's components, manufacturing process, and controls.

• Modules in DMF refer to different sections or parts of the DMF submission, each addressing specific aspects of the drug.

• Validation is the process of establishing documented evidence that a system, process, o...read more

There are two types of charge control: constant current and constant voltage.

• Constant current charge control maintains a steady flow of current to the battery until it reaches a certain voltage level.

• Constant voltage charge control maintains a steady voltage level to the battery until the current drops to a certain level.

• Examples of charge control devices include battery chargers, solar charge controllers, and power banks.

Coatings can be classified into various types based on their composition and application.

• Organic coatings - made of carbon-based compounds, used for corrosion protection and aesthetics

• Inorganic coatings - made of non-carbon-based compounds, used for high-temperature resistance and electrical insulation

• Metal coatings - made of metals like zinc, aluminum, and copper, used for corrosion protection

• Ceramic coatings - made of ceramic materials, used for wear resistance and high-tem...read more

There are several types of validation used in production processes.

• Data validation ensures that input data meets certain criteria or rules.

• Process validation ensures that a production process consistently produces the desired output.

• Equipment validation ensures that production equipment is functioning correctly and reliably.

• Cleaning validation ensures that cleaning procedures effectively remove residues or contaminants.

• Analytical validation ensures that analytical methods use...read more

Change control procedure is a process used to manage changes to a system or product in a controlled and systematic manner.

• Establish a change control board or committee to review and approve changes.

• Document all proposed changes including the reason for the change, impact analysis, and proposed implementation plan.

• Evaluate changes based on criteria such as impact on quality, cost, schedule, and risk.

• Implement changes only after approval from the change control board.

• Monitor an...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

• Data integrity ensures that data is accurate, consistent, and reliable from creation to deletion.

• ALCOA+ principles emphasize that data should be attributable to its source, legible, contemporaneous, original, accurate, and complete.

• For example, in a pharmaceutical company, maintaining d...read more

Understanding of regulatory environment is crucial for compliance and success in the market.

• Knowledge of industry-specific regulations and standards

• Understanding of government agencies overseeing regulations

• Awareness of recent regulatory changes and updates

• Compliance with data protection laws such as GDPR or HIPAA

• Importance of obtaining necessary licenses and permits

An inflatable gasket is a flexible sealing device that can be inflated to create a tight seal between two surfaces.

• An inflatable gasket is typically made of a flexible material such as rubber or silicone.

• It is designed to fit between two surfaces, such as a pipe and a flange, to prevent leakage.

• When inflated, the gasket expands and fills any gaps or irregularities in the surfaces, creating a tight seal.

• Inflatable gaskets are commonly used in industries such as manufacturing, ...read more

Powder wastes should be disposed of properly to avoid environmental hazards.

• Segregate the powder waste according to its type and toxicity level.

• Dispose of non-hazardous powder waste in regular trash bins.

• Hazardous powder waste should be collected in sealed containers and labeled properly.

• Contact a licensed waste disposal company to properly dispose of hazardous powder waste.

• Follow local and federal regulations for powder waste disposal.

• Consider recycling options for powder wa...read more

Jockey pump is a small pump used to maintain pressure in a fire protection system.

• Jockey pump is used in fire protection systems to maintain pressure in the system.

• It is a small pump that operates continuously to keep the pressure within a certain range.

• It is typically used in conjunction with larger fire pumps that are activated when the pressure drops below a certain level.

• Jockey pumps are important for ensuring that fire protection systems are always ready to operate in ca...read more

Maintaining relative humidity and temperature levels in HVAC systems is crucial for optimal performance and comfort.

• Regularly monitor and adjust the humidity and temperature levels using a humidistat and thermostat.

• Ensure proper ventilation to prevent moisture buildup and maintain air quality.

• Use dehumidifiers or humidifiers as needed to achieve the desired RH levels.

• Inspect and maintain HVAC equipment regularly to ensure efficient operation.

• Consider factors such as outdoor w...read more

The name change of ICH guidelines from previous name is ICH Harmonised Tripartite Guideline.

• The previous name was International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

• The new name is ICH Harmonised Tripartite Guideline

Various types of reactors are used in pharmaceutical industry, with GLR reactors being common. The main reaction used in pharma is typically chemical synthesis. HF gas is not used in GLR due to its corrosive nature. SSR-316 is a type of stainless steel commonly used in pharmaceutical equipment.

• Types of reactors used in pharma include GLR reactors, batch reactors, and continuous flow reactors

• Main reactions used in pharma are chemical synthesis reactions

• HF gas is not used in GL...read more

Yes, I am familiar with Alcoa, Plus, and GMP.

• Alcoa is a global leader in lightweight metals technology, engineering, and manufacturing.

• Plus is a software company that provides fleet management solutions.

• GMP stands for Good Manufacturing Practice and refers to the guidelines for ensuring the quality and safety of pharmaceutical products.

Chemical reactions involve the breaking and forming of chemical bonds to create new substances with different properties.

• Chemical reactions involve the rearrangement of atoms to form new substances

• Reactants are the starting materials and products are the end result of a chemical reaction

• Chemical reactions can be classified as exothermic or endothermic based on energy changes

• Catalysts can speed up chemical reactions without being consumed in the process

Dissolution is the process by which a solid substance dissolves in a solvent to form a solution.

• The first stage is the wetting stage, where the solid substance comes into contact with the solvent.

• The second stage is the dissolution stage, where the solid substance dissolves in the solvent.

• The third stage is the diffusion stage, where the dissolved substance diffuses away from the solid surface into the bulk of the solvent.

• The final stage is the saturation stage, where the sol...read more

Fire load can be calculated by determining the amount of combustible materials in a given area.

• Identify all combustible materials in the area

• Determine the weight or volume of each material

• Calculate the heat release rate of each material

• Add up the heat release rates to get the total fire load

• Consider the ventilation and layout of the area in the calculation

Change control is a process of managing changes to a product or system.

• It involves documenting and tracking changes

• It ensures that changes are made in a controlled and systematic manner

• It helps to minimize the risk of errors and defects

• Examples include software updates, product design changes, and process improvements

I'm sorry, but I need more context to understand the question.

• What is RMG?

• What is the context of the question?

• What type of capacity is being referred to?

Solvent classes include polar, nonpolar, protic, aprotic, and supercritical fluids.

• Polar solvents dissolve polar compounds and have a dipole moment.

• Nonpolar solvents dissolve nonpolar compounds and lack a dipole moment.

• Protic solvents have a hydrogen atom attached to an electronegative atom and can donate hydrogen bonds.

• Aprotic solvents lack a hydrogen atom attached to an electronegative atom and cannot donate hydrogen bonds.

• Supercritical fluids have properties of both a gas ...read more

A thermodynamics system refers to a region of space or a quantity of matter that is being studied in thermodynamics.

• A system can be as simple as a single object or as complex as an entire universe.

• It is separated from its surroundings by a boundary, which can be real or imaginary.

• The system can exchange energy and matter with its surroundings through this boundary.

• Thermodynamics systems are classified into open, closed, and isolated systems.

• An open system can exchange both en...read more

There are various types of deviations in production processes.

• There are three types of deviations: minor, major, and critical.

• Minor deviations are those that do not affect the quality of the product.

• Major deviations are those that affect the quality of the product but do not pose a risk to the patient.

• Critical deviations are those that pose a risk to the patient and require immediate action.

• Examples of deviations include equipment malfunction, incorrect labeling, and contamin...read more

RSD stands for Relative Standard Deviation and is a measure of the variability of a sample compared to its mean.

• RSD is calculated by dividing the standard deviation of a sample by its mean and multiplying by 100.

• It is expressed as a percentage and is often used in analytical chemistry to assess the precision of a method.

• A low RSD indicates that the data is precise and consistent, while a high RSD indicates that the data is variable and less precise.

• For example, if the mean of...read more

SCADA stands for Supervisory Control and Data Acquisition. It is a system used for monitoring and controlling industrial processes.

• SCADA systems are used in various industries such as oil and gas, water treatment, and manufacturing.

• They consist of hardware and software components that work together to collect and analyze data from sensors and other devices.

• SCADA systems allow operators to remotely monitor and control processes, making them more efficient and reducing the risk...read more

Maintaining Rh and temperature involves monitoring and adjusting humidity levels and air temperature in a controlled environment.

• Regularly monitor humidity levels using a hygrometer

• Adjust humidity levels by using a humidifier or dehumidifier as needed

• Monitor and adjust air temperature using a thermostat

• Ensure proper ventilation to prevent humidity buildup

• Use HVAC systems to regulate both humidity and temperature

Solubility studies are conducted to determine the ability of a substance to dissolve in a particular solvent.

• Solubility studies involve testing the solubility of a substance in different solvents.

• Various methods such as shake flask method, equilibrium solubility method, and kinetic solubility method can be used.

• Factors affecting solubility include temperature, pH, and particle size.

• Analytical techniques like UV-Vis spectroscopy, HPLC, and LC-MS can be used to analyze solubili...read more

To join pharma companies, one can pursue relevant education, gain experience through internships or entry-level positions, network with industry professionals, and apply for job openings.

• Pursue relevant education in pharmaceutical sciences or related fields

• Gain experience through internships or entry-level positions in the pharmaceutical industry

• Network with industry professionals through events, conferences, and online platforms

• Stay updated with industry trends and advanceme...read more

Pharmacology is the study of drugs and their effects on living organisms.

• Pharmacology involves the study of how drugs interact with biological systems.

• It includes the study of drug absorption, distribution, metabolism, and excretion.

• Pharmacology also covers the study of drug development, safety, and efficacy.

• Examples of pharmacology include the study of antibiotics, chemotherapy drugs, and painkillers.

• Pharmacologists work to develop new drugs and improve existing ones.

m/z ratio is the mass-to-charge ratio of an ion in mass spectrometry.

• m/z ratio is used to identify and quantify molecules in a sample.

• It is calculated by dividing the mass of an ion by its charge.

• The resulting value is used to plot the mass spectrum of a sample.

• For example, a molecule with a mass of 100 Da and a charge of +1 would have an m/z ratio of 100.

• Different molecules can have the same m/z ratio, so additional techniques are used to identify them.

Guidelines for packaging development in ROW and generic markets

• ROW (Rest of the World) markets have varying regulations and guidelines for packaging development

• Generic markets require adherence to strict guidelines for packaging development

• Packaging must comply with local regulations and guidelines for each market

• Packaging must be designed to protect the product and ensure its stability

• Packaging must be cost-effective and efficient for manufacturing and distribution

• Examples o...read more

RTD sensor stands for Resistance Temperature Detector sensor. It is a type of temperature sensor that operates on the principle of the temperature dependence of electrical resistance of metals.

• RTD sensors are commonly used in industrial applications for temperature measurement due to their high accuracy and stability.

• They are often made of platinum, nickel, or copper and have a linear relationship between resistance and temperature.

• RTD sensors are used in HVAC systems, automo...read more

Relative humidity is the amount of water vapor present in air compared to the maximum amount it can hold at a specific temperature, while humidity is the general term for the amount of water vapor in the air.

• Relative humidity is expressed as a percentage, while humidity is a general term for the amount of water vapor in the air.

• Relative humidity changes with temperature, while humidity is a measure of the water vapor content in the air.

• For example, if the relative humidity is...read more

Mechanical calibration of Dissolution Apparatus involves ensuring the apparatus is functioning accurately and consistently.

• Calibration involves checking the alignment of the shaft, speed of rotation, temperature control, and vessel centering.

• Regular calibration is necessary to ensure accurate and reliable dissolution testing results.

• Examples of calibration methods include using standard weights for balance calibration and checking the rotation speed with a tachometer.

• Calibrat...read more

FBD stands for Fluidized Bed Dryer, a process used in the pharmaceutical industry for drying granules and powders.

• FBD is a widely used process in the pharmaceutical industry for drying granules and powders.

• It involves passing hot air through a bed of particles, causing them to fluidize and dry evenly.

• The process is efficient and can be used for both batch and continuous drying.

• FBD is also used in other industries such as food and chemical processing.

• Examples of products that ...read more

The procedure for OOS as per guidelines involves investigation, documentation, and corrective action.

• Investigate the root cause of the OOS result

• Document the investigation process and findings

• Take corrective action to prevent recurrence

• Notify relevant parties, such as management and regulatory agencies

• Review and evaluate the effectiveness of the corrective action taken

API and ICHQ7 are guidelines for maintenance management in pharmaceutical industry.

• API (Active Pharmaceutical Ingredient) guidelines provide standards for the quality of raw materials used in pharmaceutical manufacturing.

• ICHQ7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) provides guidelines for Good Manufacturing Practices (GMP) in the pharmaceutical industry.

• Maintenance management in the pharmaceutica...read more

A micron filter is a type of filter used to remove particles and contaminants from a fluid by trapping them based on their size.

• Micron filters are commonly used in industries such as pharmaceuticals, food and beverage, and electronics manufacturing.

• They are designed to capture particles of a specific size, typically ranging from 0.1 to 10 microns.

• Micron filters can be made of various materials such as polypropylene, nylon, or ceramic.

• Examples of applications include filtering...read more

Profit in marketing refers to the financial gain achieved through successful marketing efforts.

• Profit in marketing is the monetary return on investment from marketing activities.

• It is the difference between the revenue generated from sales and the cost of marketing.

• Marketing profit can be increased by increasing sales, reducing marketing expenses, or improving marketing efficiency.

• Examples of marketing profit include increased market share, higher customer retention, and impr...read more

The number of load cells required depends on the production process and equipment being used.

• The number of load cells needed varies depending on the type of equipment and production process.

• Load cells are used to measure weight or force in a production process.

• For example, a packaging line may require multiple load cells to ensure accurate filling of products.

• The number of load cells needed should be determined by a production engineer or equipment manufacturer.

• Factors such a...read more

Maintaining differential pressure involves regular monitoring, adjusting airflow, and ensuring proper equipment functioning.

• Regularly monitor differential pressure readings to ensure they are within the desired range

• Adjust airflow by adjusting dampers, fan speeds, or air vents to maintain the correct pressure

• Ensure proper functioning of equipment such as filters, fans, and ductwork to prevent pressure imbalances

• Perform routine maintenance and inspections to identify and addre...read more

Yes, deviation refers to the difference between the actual and expected outcome.

• Deviation is a measure of how far a result is from the expected outcome.

• It can be positive or negative depending on whether the actual result is higher or lower than expected.

• In production, deviation can refer to variations in quality or quantity of output.

• For example, if a machine is expected to produce 100 units per hour but only produces 90, the deviation is -10%.

Difficult local employees can be handled by understanding their cultural background, communicating effectively, setting clear expectations, and providing support.

• Understand their cultural background and values

• Communicate effectively and listen actively

• Set clear expectations and boundaries

• Provide support and resources

• Address any performance or behavior issues promptly

• Offer training and development opportunities

• Recognize and appreciate their contributions

• Seek feedback and conti...read more

Hydraulic and pneumatic circuits are used in machinery to transmit power using fluids or gases.

• Hydraulic circuits use oil as the fluid to transmit power, while pneumatic circuits use air or gas.

• Both circuits consist of a pump/compressor, valves, actuators, and reservoirs.

• Hydraulic circuits are used in heavy machinery like excavators, while pneumatic circuits are used in tools like air compressors.

• Hydraulic circuits provide more power but pneumatic circuits are cleaner and eas...read more

Pharmaceutics is the study of the design, development, and formulation of drugs.

• It involves the creation of new drugs and the improvement of existing ones.

• Pharmaceutics also deals with the delivery of drugs to the body, including dosage forms and drug delivery systems.

• It encompasses various fields such as physical chemistry, pharmacology, and pharmacokinetics.

• Examples of pharmaceutics include the development of extended-release tablets, transdermal patches, and inhalers.

• Pharm...read more

Ipca Laboratories Limited is a pharmaceutical company based in Mumbai, India.

• Founded in 1949

• Manufactures and markets over 350 formulations and 80 APIs

• Exports to over 120 countries

• Has manufacturing facilities in India, North America, and Europe

• Specializes in the production of anti-malarial drugs

Grant of Factory licence involves submission of required documents and compliance with safety regulations.

• Application form submission

• Site inspection by authorities

• Submission of building plan and layout

• Compliance with safety regulations like fire safety measures

• Approval from various departments like pollution control board

• Renewal of licence periodically

Marketing is the process of promoting and selling products or services by understanding customer needs and creating value.

• Marketing involves identifying customer needs and wants.

• It includes creating and communicating value propositions.

• Marketing strategies aim to attract, retain, and satisfy customers.

• It involves market research, product development, pricing, promotion, and distribution.

• Examples: advertising campaigns, social media marketing, market segmentation.

The refrigeration cycle is a thermodynamic process that removes heat from a space or substance to lower its temperature.

• The cycle consists of four main components: compressor, condenser, expansion valve, and evaporator.

• The compressor increases the pressure and temperature of the refrigerant gas.

• The high-pressure gas then flows into the condenser where it releases heat and condenses into a high-pressure liquid.

• The liquid refrigerant passes through the expansion valve, which re...read more

The question is incomplete or unclear.

• There seems to be a typo or missing information in the question.

• Without proper context, it is impossible to provide a meaningful answer.

• Please clarify the question or provide more information.

DMF stands for Drug Master File, which is a submission to the FDA containing confidential information about the manufacturing, processing, and packaging of a drug substance or drug product.

• DMF is a submission made to the FDA by a drug manufacturer.

• It contains confidential information about the manufacturing, processing, and packaging of a drug substance or drug product.

• DMF is used to support the safety, efficacy, and quality of a drug product.

• DMF is not a regulatory approval,...read more

A product dossier is a comprehensive document that contains all the information related to a product.

• It includes information about the product's development, manufacturing, quality control, and clinical trials.

• It is used to support regulatory submissions and approvals.

• Examples of product dossiers include drug master files and device master files.

• It is important for the dossier to be accurate and up-to-date to ensure the safety and efficacy of the product.

Differential pressure is the difference in pressure between two points in a system.

• Differential pressure is used to measure the pressure drop across a filter, coil, or other HVAC component.

• It is important in HVAC systems to ensure proper airflow and efficiency.

• Differential pressure is typically measured in inches of water column (in. w.c.) or pascals (Pa).

The human anatomy is the study of the structure and organization of the human body. The pharma industry refers to the sector involved in the research, development, production, and marketing of pharmaceutical drugs.

• Human anatomy is a branch of biology that focuses on the structure and function of the human body.

• It involves studying various systems and organs, such as the skeletal, muscular, cardiovascular, and respiratory systems.

• Understanding human anatomy is crucial in the p...read more

Yes, CCP stands for Critical Control Points and CAPA stands for Corrective and Preventive Actions.

• CCP is a step in the production process where control can be applied to prevent, eliminate or reduce a hazard to an acceptable level.

• CAPA is a process used to investigate and address the root cause of a problem or non-conformance, and to prevent it from recurring.

• Both CCP and CAPA are important tools in ensuring product quality and safety in the production process.

Regular maintenance of HVAC systems is essential for optimal performance and energy efficiency.

• Change air filters regularly to ensure proper airflow and indoor air quality.

• Inspect and clean evaporator and condenser coils to improve efficiency.

• Check refrigerant levels and ensure there are no leaks.

• Inspect and clean ductwork to prevent blockages and improve airflow.

• Regularly schedule professional maintenance to identify and address any issues before they become major problems.

Differential pressure is the difference in pressure between two points in a system.

• Difference pressure, also known as differential pressure, is the variance in pressure between two points in a system.

• It is commonly used in HVAC systems to measure the pressure drop across filters, coils, or ducts.

• Differential pressure is crucial for ensuring proper airflow and system efficiency.

• It is typically measured in units such as inches of water column (in. w.c.) or pascals (Pa).

An HVAC system is a heating, ventilation, and air conditioning system that regulates temperature, humidity, and air quality in a building.

• HVAC systems control temperature, humidity, and air quality in a building

• They consist of components such as furnaces, air conditioners, ductwork, and thermostats

• HVAC systems can be centralized or decentralized

• Regular maintenance is important to ensure efficient operation

Validation process is a methodical approach to ensuring that a system or process meets predefined requirements and specifications.

• Validation process involves testing and verifying that a system or process performs as intended.

• It includes documenting and analyzing results to ensure compliance with standards.

• Validation process may involve validation protocols, test plans, and validation reports.

• Examples of validation processes include equipment validation in pharmaceutical manu...read more

GMP stands for Good Manufacturing Practice and DI stands for Deionized Water.

• GMP is a set of guidelines that ensure the quality and safety of pharmaceutical products.

• DI water is a type of purified water that has had all ions removed.

• GMP compliance is mandatory for pharmaceutical companies to ensure product safety and efficacy.

• DI water is commonly used in laboratory experiments and medical equipment cleaning.

• GMP regulations cover everything from facility design to employee tra...read more

A high exothermic reaction is a chemical reaction that releases a large amount of heat energy.

• High exothermic reactions are characterized by a significant increase in temperature during the reaction.

• These reactions often involve the release of heat energy to the surroundings.

• Examples include combustion reactions, such as burning wood or gasoline.

• Exothermic reactions are commonly used in industrial processes to generate heat or power.

A flow diagram of an ETP shows the process of treating wastewater before it is discharged into the environment.

• The flow diagram typically includes the different stages of treatment, such as screening, sedimentation, and disinfection.

• It may also show the equipment used in each stage, such as pumps, filters, and chemical dosing systems.

• The diagram should indicate the flow of water through the system, including any recirculation or reuse of treated water.

• The final stage of the p...read more

Marketing is the process of promoting and selling products or services by understanding customer needs and creating strategies to reach and engage with them.

• Marketing involves identifying target customers and their needs

• It includes creating and implementing strategies to promote products or services

• Marketing aims to attract and retain customers

• It utilizes various channels such as advertising, social media, and public relations

• Examples of marketing activities include market re...read more

QA stands for Quality Assurance, which is a process of ensuring that products or services meet specified requirements and are free from defects.

• QA involves planning, designing, implementing, and analyzing tests to ensure quality standards are met.

• It focuses on preventing defects rather than detecting them after production.

• QA helps in improving processes and identifying areas for improvement.

• Examples of QA activities include test planning, test case development, and test execu...read more

Packaging materials are materials used to protect, contain, and transport products.

• Packaging materials can include boxes, bags, bottles, jars, cans, and tubes.

• They can also include materials like bubble wrap, foam, paper, and plastic film.

• Packaging materials are essential for ensuring products are safely delivered to customers.

• They can also play a role in marketing and branding of products.

Marketing is the process of promoting and selling products or services through various strategies and tactics.

• Marketing involves identifying target audiences and understanding their needs and preferences.

• It includes creating and implementing marketing campaigns to reach and engage with customers.

• Marketing also involves conducting market research to gather insights and make informed decisions.

• It encompasses various channels such as advertising, public relations, social media, ...read more

Regular requirements for USFDA include data integrity.

• USFDA requires companies to maintain accurate and complete records of their manufacturing processes and quality control measures.

• Data integrity is essential to ensure that the information submitted to the USFDA is reliable and trustworthy.

• Companies must have systems in place to prevent data manipulation, unauthorized access, and data loss.

• USFDA may conduct inspections to verify compliance with data integrity requirements.

• F...read more

Deviation refers to the act of departing from the usual or accepted standards, especially in a production process.

• Deviation can occur when a product does not meet the specified requirements or standards.

• It can also refer to a change in a process or procedure that was not authorized.

• Deviation must be documented and investigated to determine the root cause and prevent recurrence.

• Examples of deviation include using incorrect materials in production, skipping a step in a process,...read more

Chemical concept refers to a fundamental idea or principle in the field of chemistry.

• Chemical concepts are foundational knowledge that help explain the behavior and properties of substances.

• Examples of chemical concepts include atomic structure, chemical bonding, and reaction kinetics.

• Understanding chemical concepts is essential for conducting experiments, analyzing data, and solving problems in chemistry.

• Chemical concepts are often taught in introductory chemistry courses an...read more

Mode of action molecules are compounds that target specific biological pathways to achieve a desired therapeutic effect.

• Mode of action molecules interact with specific targets in the body to produce a pharmacological response.

• Examples include antibiotics targeting bacterial cell walls, antidepressants affecting neurotransmitter levels, and chemotherapy drugs inhibiting cancer cell growth.

• Understanding the mode of action of molecules is crucial for developing effective treatme...read more