70+ 1Box Tickets Interview Questions and Answers

Surface monitoring is a process of regularly testing and evaluating the cleanliness and microbial contamination levels on surfaces in a controlled environment.

• Surface monitoring involves taking samples from various surfaces, such as equipment, workstations, and cleanrooms.

• These samples are then analyzed for the presence of microorganisms, such as bacteria, fungi, and viruses.

• Surface monitoring helps to ensure that the environment is free from harmful contaminants and meets th...read more

Flow through collection is a process of continuous sample collection while fraction collection is the process of collecting specific portions of a sample.

• Flow through collection involves collecting a continuous stream of sample without interruption

• Fraction collection involves collecting specific portions of a sample based on predetermined criteria

• Both processes are commonly used in chromatography and other analytical techniques

• Flow through collection is useful for obtaining a...read more

Environment monitoring in QC microbiology involves regular sampling and testing of the manufacturing environment to ensure cleanliness and control of microbial contamination.

• Sampling of air, surfaces, and water sources

• Use of agar plates, swabs, or settle plates for collection

• Incubation of samples to allow microbial growth

• Identification and enumeration of microbial colonies

• Analysis of results to assess the level of contamination and take corrective actions

• Regular monitoring an...read more

The molecular weight of the target protein is unknown.

• The molecular weight of a protein is the sum of the atomic weights of all the atoms in the protein molecule.

• It is an important parameter for protein purification and characterization.

• The molecular weight can be determined using techniques such as mass spectrometry or gel electrophoresis.

USP guidelines for microbiology focus on ensuring the safety and quality of pharmaceutical products.

• USP guidelines provide standards for testing and evaluating microbiological aspects of pharmaceutical products.

• These guidelines cover areas such as microbial limits, sterility testing, and environmental monitoring.

• They aim to prevent contamination, ensure product efficacy, and protect patient safety.

• For example, USP <61> and <62> provide methods for microbial enumeration and te...read more

The overall pH and conductivity of the DS depend on the specific DS being referred to.

• The pH and conductivity of different DS can vary widely depending on their composition and intended use.

• For example, the pH of a cleaning solution DS may be around 10-11, while the pH of a battery electrolyte DS may be around 1-2.

• Similarly, the conductivity of a DS used in electronics manufacturing may be very low, while the conductivity of a DS used in metal plating may be very high.

CEX Fraction pooling is done based on the desired purity and yield of the final product.

• CEX Fraction pooling is a process used in protein purification.

• It involves combining multiple fractions from a cation exchange chromatography column.

• The fractions are pooled based on the desired purity and yield of the final product.

• Factors such as protein concentration, pH, and buffer composition are also considered.

• CEX Fraction pooling can help improve the overall efficiency and yield of...read more

Ultrafiltration is a process of separating molecules based on their size using a semipermeable membrane. Diafiltration is a process of washing the separated molecules to remove impurities.

• Ultrafiltration is used in industries such as food and beverage, pharmaceuticals, and biotechnology to purify and concentrate solutions.

• Diafiltration is commonly used in protein purification to remove salts and other impurities from the solution.

• Both ultrafiltration and diafiltration are imp...read more

I have used various softwares for data analysis including R, Python, Excel, and SPSS.

• R

• Python

• Excel

• SPSS

Regulatory affairs involves ensuring compliance with regulations and guidelines set by government agencies for products and processes.

• Regulatory affairs involves interpreting and implementing regulations set by government agencies.

• It includes obtaining and maintaining approvals for products and processes.

• Knowledge of eCTD sections is important for submitting electronic regulatory submissions.

• LCM stands for Life Cycle Management, which involves managing a product throughout it...read more

Pharma guidelines are regulations and standards set by regulatory bodies to ensure safety and efficacy of pharmaceutical products.

• Pharmaceutical products must undergo rigorous testing and clinical trials before being approved for use.

• Manufacturing facilities must adhere to strict quality control standards.

• Pharmaceutical companies must comply with regulations regarding labeling, advertising, and promotion of their products.

• Pharmacovigilance is important to monitor and report a...read more

Flow-through is collected during AEX chromatography to separate unbound molecules from the target molecule bound to the resin.

• Flow-through contains molecules that did not bind to the resin

• Target molecule is retained on the resin due to interactions with the stationary phase

• Flow-through is collected to isolate the target molecule for further analysis

Yes, I have experience operating equipment used for manufacturing injectables.

• I have worked with various types of equipment used in the manufacturing of injectables, including filling machines, lyophilizers, and autoclaves.

• I am familiar with the standard operating procedures for each piece of equipment and have received training on their proper use and maintenance.

• I understand the importance of following strict protocols and maintaining a sterile environment when working with...read more

I have experience in managing biosimilar global clinical trials.

• I have managed clinical trials for biosimilars in multiple countries

• I am familiar with regulatory requirements for biosimilar trials

• I have experience in managing CROs and vendors for biosimilar trials

• I have worked with cross-functional teams including medical, regulatory, and commercial teams

• I am knowledgeable about the challenges and opportunities in biosimilar development

Aseptic growing procedures involve maintaining a sterile environment to prevent contamination in the growth of microorganisms or cells.

• Aseptic techniques are used in various fields such as microbiology, pharmaceuticals, and tissue culture.

• Key principles include sterilization of equipment, proper handwashing, use of sterile media and containers, and minimizing exposure to air and surfaces.

• Examples of aseptic growing procedures include the preparation of agar plates in a lamina...read more

RLD is a reference listed drug while in-house formulation is developed by the company itself.

• RLD is an already approved drug that serves as a reference for generic drug development

• In-house formulation is developed by the company itself and may or may not have an RLD

• RLD is used to establish bioequivalence of generic drugs

• In-house formulation may have unique characteristics or advantages over RLD

Ion exchange chromatography separates proteins based on their net charge, with different types and exchange capacities. pH affects protein binding.

• Ion exchange chromatography separates proteins based on their net charge

• Types include cation exchange (positively charged proteins bind to negatively charged resin) and anion exchange (negatively charged proteins bind to positively charged resin)

• Exchange capacity refers to the amount of charge that can be exchanged on the resin

• pH o...read more

A grade aseptic area is a highly controlled environment with low levels of airborne particles to prevent contamination.

• Aseptic areas are used in pharmaceutical and medical industries for sterile manufacturing and packaging.

• The area is designed to minimize the introduction of contaminants, such as dust, bacteria, and viruses.

• The air is filtered and circulated to maintain positive pressure and prevent outside air from entering.

• Personnel must wear specialized clothing and follow...read more

TFF stands for Tangential Flow Filtration. The molecule with the smallest molecular weight will elute out first in Size Exclusion Chromatography (SSC).

• TFF is a filtration technique used to separate molecules based on size

• Size Exclusion Chromatography (SSC) separates molecules based on size and shape

• The molecule with the smallest molecular weight will elute out first in SSC

Single quadrupole and triple quadrupole differ in the number of quadrupole mass analyzers used in the instrument.

• Single quadrupole uses one quadrupole mass analyzer, while triple quadrupole uses three.

• Single quadrupole is used for qualitative analysis, while triple quadrupole is used for quantitative analysis.

• Triple quadrupole offers better sensitivity and selectivity compared to single quadrupole.

• Triple quadrupole allows for multiple reaction monitoring (MRM) experiments.

• Tri...read more

Protein binding to resin is a process where proteins are immobilized onto a solid support matrix.

• Resin is typically made of a porous material such as agarose or cellulose beads

• Proteins bind to the resin through various interactions such as hydrogen bonding, electrostatic interactions, and hydrophobic interactions

• This process is commonly used in protein purification and chromatography techniques

• The choice of resin and binding conditions depend on the specific protein being pur...read more

Genes are selected based on their potential role in a specific biological process or disease.

• Identify the biological process or disease of interest

• Consult existing literature and databases to identify candidate genes

• Prioritize genes based on their known function and relevance to the process/disease

• Use genetic engineering techniques to knock out the selected genes

• Analyze the resulting phenotype to confirm the gene's role

ALCOA+ is a framework for ensuring data integrity in clinical research.

• ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, and Secured.

• It is used in clinical research to ensure that data is reliable and can be trusted.

• For example, data should be attributable to the person who collected it, legible and easy to read, and recorded in a timely manner.

• ALCOA+ also requires that data is accurate, complete, consiste...read more

Isoelectric point is the pH at which a molecule has no net charge.

• It is the pH at which a molecule has equal number of positive and negative charges.

• It is also known as the pI.

• At the isoelectric point, a molecule will not migrate in an electric field.

• It is important in protein purification and separation techniques.

AWFI can be qualified through testing and certification processes.

• AWFI can be qualified through third-party testing and certification processes

• Testing may include performance, safety, and environmental standards

• Certification may be required by regulatory bodies or industry associations

• Examples of AWFI certification programs include UL, CE, and ISO

• Qualification may also involve audits of manufacturing processes and quality control measures

Chromatography is a technique used to separate and analyze mixtures of chemicals based on their properties.

• Chromatography involves a stationary phase (solid or liquid) and a mobile phase (gas or liquid).

• Components include a sample to be separated, a column or plate for separation, a solvent for the mobile phase, and a detector for analyzing separated components.

• Types of chromatography include gas chromatography, liquid chromatography, and thin-layer chromatography.

• Chromatogra...read more

Post translational modification refers to the chemical modification of a protein after it has been synthesized.

• Common modifications include phosphorylation, glycosylation, and acetylation.

• These modifications can alter the protein's function, stability, and localization.

• Examples of post translational modification include the addition of a phosphate group to a serine or threonine residue, or the addition of a sugar molecule to an asparagine residue.

• Post translational modificati...read more

The interview questions were related to reactor design, fermentation, and impeller power number.

• Power number is a dimensionless number used to describe the power consumption of an impeller in a reactor.

• Fermentation is a process in which microorganisms are used to produce a desired product, such as ethanol or antibiotics.

• Biocon is a leading biopharmaceutical company that specializes in the development and manufacture of innovative therapies.

• The impeller with the highest power ...read more

Negotiable on CTC depends on the company's policies and the candidate's experience and skills.

• CTC negotiation is common in the industry.

• The company may have a fixed salary structure or may be open to negotiation.

• The candidate's experience and skills can influence the negotiation.

• Other benefits like health insurance, bonuses, and vacation time can also be negotiated.

• It's important to research industry standards and company policies before negotiating.

Ion exchange chromatography is a technique used to separate and purify proteins and other charged molecules based on their net charge.

• Separates molecules based on their charge

• Uses a stationary phase with charged groups to attract and bind charged molecules

• Elution is achieved by changing the ionic strength or pH of the mobile phase

• Commonly used in protein purification and analysis

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

• Ensuring data is accurate and reliable

• Maintaining consistency of data

• Preventing unauthorized access or modifications

• Implementing security measures to protect data integrity

NWP stands for Normalized Water Permeability in Tangential Flow Filtration (TFF).

• NWP is a measure of the water permeability of a TFF membrane normalized by its surface area and thickness.

• It is used to evaluate the performance of TFF membranes in terms of their ability to retain solutes while allowing water to pass through.

• Higher NWP values indicate better membrane performance.

• NWP is affected by factors such as membrane material, pore size, and operating conditions.

• For example...read more

Microbial limits are set for all grades of products to ensure safety and quality.

• Microbial limits are the maximum allowable levels of microorganisms in a product.

• These limits vary depending on the grade of the product and its intended use.

• For example, pharmaceutical products have stricter microbial limits than food products.

• The limits are set by regulatory agencies such as the FDA and are based on scientific research and risk assessment.

• Testing is done to ensure that products...read more

The number of test parameters for assay test using Alcoa plus is dependent on the specific requirements of the test.

• The number of test parameters will vary depending on the specific assay test being performed.

• Alcoa plus is a data integrity framework used in the pharmaceutical industry.

• The calculation for assay test parameters may include factors such as sample size, concentration, and purity.

• It is important to carefully define and document all test parameters to ensure accura...read more

Power factor is the ratio of real power to apparent power in an AC circuit.

• Power factor helps in determining the efficiency of an electrical system.

• A high power factor indicates that the system is using power efficiently.

• A low power factor indicates that the system is not using power efficiently and can result in higher energy bills.

• Power factor correction techniques can be used to improve the power factor of a system.

• Examples of devices that can improve power factor include ...read more

Stability studies for biologicals are essential to ensure their safety and efficacy.

• Stability studies involve testing the biological product under various conditions to determine its shelf life and storage requirements.

• Factors such as temperature, humidity, light exposure, and pH can affect the stability of biologicals.

• Stability testing is conducted at different stages of product development, including preclinical and clinical phases.

• The results of stability studies are used ...read more

Process flow is the sequence of steps involved in the production of a product or service.

• Process flow outlines the steps required to complete a task or project

• It helps to identify bottlenecks and areas for improvement

• Examples include manufacturing processes, software development, and customer service workflows

Deviation refers to the act of departing from the usual or accepted standard.

• Deviation can be seen as a divergence or deviation from a set norm or standard.

• In statistics, deviation refers to the difference between an observed value and the mean value in a dataset.

• Deviation can also refer to a departure from a planned or expected course of action.

• Examples of deviation include a student deviating from the school's dress code, or a project deviating from its original timeline.

Natco Pharma Ltd Hyderabad has been in operation for 3 years.

• Natco Pharma Ltd Hyderabad has been operating since 2018.

• The company is based in Hyderabad.

• Natco Pharma is involved in the manufacturing and marketing of pharmaceutical products.

• The company has a diverse product portfolio including generic drugs, active pharmaceutical ingredients (APIs), and formulations.

• Natco Pharma has a strong presence in both domestic and international markets.

• The company has received several re...read more

DG synchronizing factors are the parameters that ensure the proper synchronization of multiple generators in a power system.

• DG synchronizing factors include frequency, voltage, phase angle, and rate of change of frequency.

• These factors must be carefully monitored and adjusted to ensure that the generators are operating in sync and not causing any damage to the power system.

• For example, if the frequency of one generator is slightly higher than the others, it will start to supp...read more

The pH formula is used to calculate the acidity or alkalinity of a solution. Molarity is a measure of the concentration of a solute in a solution. The pH scale is a logarithmic scale that ranges from 0 to 14, with 7 being neutral.

• pH formula calculates the negative logarithm of the hydrogen ion concentration in a solution

• Molarity is the number of moles of solute per liter of solution

• The pH scale ranges from 0 to 14, with values below 7 being acidic, 7 being neutral, and values...read more

I don't have the available data.

• Sorry, I don't have access to the information regarding the number of phase 3 trials visited.

• Without the specific context of the company or project, I cannot provide an accurate answer.

The process from vial thaw involves gradually warming the frozen vial to room temperature before use.

• Remove the vial from the freezer and allow it to thaw at room temperature

• Avoid rapid thawing to prevent damage to the contents

• Once thawed, gently mix the contents before use

Laminar airflow is a smooth, uninterrupted flow of air in a consistent direction.

• Laminar airflow moves in parallel layers with minimal turbulence

• It is typically achieved through the use of HEPA filters in cleanrooms and operating theaters

• Laminar airflow helps to reduce the risk of contamination in controlled environments

The scale handle reaction depends on the weight being measured and the force applied to the handle.

• The scale handle reaction increases as the weight being measured increases.

• The scale handle reaction decreases as the force applied to the handle decreases.

• The scale handle reaction can be calculated using the formula: reaction = weight * force.

Water system qualification methods ensure water quality meets regulatory standards.

• Water system validation through performance testing

• Regular monitoring of water quality parameters

• Documentation of procedures and results

• Compliance with regulatory requirements such as USP <1231> for pharmaceutical water systems

Good Manufacturing Practices (GMP) are guidelines that ensure products are consistently produced and controlled according to quality standards.

• GMP guidelines are designed to minimize risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

• They cover all aspects of production, from the materials used to the hygiene and training of staff.

• Examples of GMP include maintaining clean facilities, proper documentation of processes, a...read more

Biosimilars are similar but not identical to the original biologic drug, while generics are identical copies of the original small molecule drug.

• Biosimilars are made from living cells and are more complex than small molecule generics.

• Biosimilars undergo a rigorous approval process to ensure they are similar in safety and efficacy to the original biologic drug.

• Generics are cheaper than the original drug and have the same active ingredient, dosage form, and route of administrat...read more

Expected job profile includes managing production processes and ensuring timely delivery. Expected facility should have necessary equipment and resources.

• Job profile involves overseeing production processes and ensuring quality standards are met

• Responsible for managing production schedules and ensuring timely delivery of products

• Expected facility should have necessary equipment and resources to support production processes

• Facility should also have proper safety measures in pl...read more

SDS-PAGE is a technique used to separate proteins based on their size and charge. ELISA is a method to detect and quantify specific proteins or antibodies in a sample.

• SDS-PAGE stands for Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis

• It is commonly used in biochemistry and molecular biology to analyze protein samples

• SDS-PAGE separates proteins based on their molecular weight

• ELISA stands for Enzyme-Linked Immunosorbent Assay

• It is a widely used technique in immunology...read more

Generic drugs are identical copies of brand-name drugs with the same active ingredients, dosage, strength, and route of administration. Biosimilars are highly similar versions of biologic drugs.

• Generic drugs are typically cheaper than brand-name drugs and are approved by regulatory authorities after demonstrating bioequivalence.

• Biosimilars are not exact copies of biologic drugs but are highly similar in terms of safety, efficacy, and quality.

• Examples of generic drugs include ...read more

ICH guidelines provide recommendations for the development and registration of biological products.

• ICH guidelines cover topics such as quality, safety, and efficacy of biological products

• Guidelines include specific requirements for clinical trials and post-marketing surveillance

• Examples of ICH guidelines for biologicals include Q5A(R1) on quality of biotechnological products and Q6B on specifications for biotechnological products

Clinical research data refers to the information collected during a clinical trial or study to evaluate the safety and effectiveness of a medical intervention.

• Clinical research data includes various types of information such as patient demographics, medical history, laboratory test results, and treatment outcomes.

• It is collected through various methods such as interviews, questionnaires, physical examinations, and medical tests.

• The data is carefully recorded, organized, and a...read more

I am currently covering hospitals in the northern region of the state, including City Hospital and County Medical Center.

• City Hospital

• County Medical Center

• Northern Regional Hospital

I am currently earning a CTC of X and my notice period is Y.

• My current CTC is X.

• My notice period is Y.

HVAC qualification procedures involve certification, training, and experience in heating, ventilation, and air conditioning systems.

• Certification from recognized organizations like NATE or HVAC Excellence is important

• Training programs and courses in HVAC technology are beneficial

• Hands-on experience in installing, maintaining, and repairing HVAC systems is crucial

• Continuing education to stay updated on industry standards and regulations

Temperature mapping procedures are used to ensure proper temperature control in various environments.

• Temperature mapping involves strategically placing temperature sensors throughout a space to monitor temperature variations.

• Data collected from temperature mapping is used to identify hot spots, cold spots, and areas of temperature fluctuation.

• Regular temperature mapping is essential for industries like pharmaceuticals, food storage, and healthcare to comply with regulations.

• T...read more

Document handling during AUDIT process

• During AUDIT process, all relevant documents must be handled with utmost care

• Documents must be organized and easily accessible for auditors

• Any missing or incomplete documents must be identified and addressed

• Proper documentation of the audit process is crucial for future reference

Acid and base are two types of chemical compounds with distinct properties.

• Acids are substances that release hydrogen ions (H+) when dissolved in water.

• Bases are substances that release hydroxide ions (OH-) when dissolved in water.

• Acids have a sour taste and can corrode metals.

• Bases have a bitter taste and feel slippery to the touch.

• Examples of acids include hydrochloric acid (HCl) and sulfuric acid (H2SO4).

• Examples of bases include sodium hydroxide (NaOH) and ammonia (NH3).

DSP stands for Digital Signal Processing, which involves manipulating digital signals to improve their quality or extract useful information.

• DSP involves analyzing, modifying, and synthesizing digital signals.

• Processes in DSP include filtering, noise reduction, compression, and modulation.

• DSP is used in audio processing, image processing, telecommunications, and radar systems.

USP stands for Unique Selling Proposition, which is a factor that differentiates a product or service from its competitors. Process refers to the series of actions or steps taken to achieve a particular goal.

• USP is a unique feature or benefit that sets a product or service apart from others in the market

• Process is a systematic series of actions or steps taken to achieve a specific goal or outcome

• USP helps in attracting customers by highlighting what makes a product or service...read more

OSPF is a link-state protocol while EIGRP is a distance-vector protocol.

• OSPF uses Dijkstra's algorithm to calculate the shortest path while EIGRP uses a proprietary algorithm.

• OSPF supports multiple paths to a destination while EIGRP only supports a single path.

• OSPF is more scalable and suited for larger networks while EIGRP is better for smaller networks.

• OSPF uses multicast for updates while EIGRP uses unicast.

• OSPF has a higher convergence time than EIGRP.

• OSPF is an open stan...read more

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 such...read more

I have extensive monitoring experience in project management.

• I regularly track project progress and identify potential risks.

• I use various tools and techniques to monitor project performance.

• I communicate progress updates to stakeholders and adjust plans as needed.

• I have experience with both agile and waterfall project management methodologies.

• For example, in my previous role, I implemented a daily stand-up meeting to monitor progress and identify roadblocks.

• I also used earne...read more

Answered the question about current and expected CTC.

• Shared the current CTC and expected CTC.

• Explained the reason for expecting the new CTC.

• Mentioned any additional benefits or perks expected.

• Discussed the possibility of negotiation.

• Maintained a professional and polite tone throughout the conversation.

GMP stands for Good Manufacturing Practice, a set of guidelines ensuring products are consistently produced and controlled according to quality standards.

• GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.

• It covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.

• Examples of GMP requirements include proper documentation, validation of pro...read more

Gene therapy is a medical technique that involves modifying genes to treat or prevent diseases.

• Gene therapy involves inserting, deleting, or modifying genes within an individual's cells.

• It can be used to treat genetic disorders, cancer, and certain viral infections.

• Examples include using gene therapy to replace a faulty gene causing a genetic disease, or to enhance the immune system to target cancer cells.

Waterplant operation involves treating and purifying water for consumption.

• Water is sourced from a natural or artificial source

• The water is screened to remove large debris

• Chemicals are added to coagulate and remove smaller particles

• The water is filtered to remove remaining impurities

• Disinfectants are added to kill any remaining bacteria or viruses

• The water is then stored and distributed for consumption

OSI Layer is a conceptual model that describes the communication functions of a telecommunication system.

• OSI stands for Open Systems Interconnection

• It consists of 7 layers, each with a specific function

• Layer 1 is the physical layer, responsible for transmitting raw data over a physical medium

• Layer 2 is the data link layer, responsible for error-free transfer of data between nodes on a network

• Layer 3 is the network layer, responsible for routing and forwarding data between dif...read more