30+ Axio Interview Questions and Answers

Process validation is a documented evidence that ensures consistent production of products meeting predetermined specifications.

• Process validation provides a high degree of assurance for consistent product quality.

• It involves establishing documented evidence that a specific process consistently produces products meeting predetermined specifications.

• There are different types of process validation, including process validation, concurrent validation, retrospective validation, a...read more

The problem in tablet coating can be due to uneven coating, cracking, or sticking. It can be solved by adjusting the coating process or using different coating materials.

• Uneven coating can be solved by adjusting the spray rate or the distance between the nozzle and the tablet.

• Cracking can be solved by using a plasticizer in the coating material or adjusting the drying temperature.

• Sticking can be solved by using an anti-adherent in the coating material or adjusting the tablet ...read more

Yes, I am aware of LIMS, ALCOA+, and working in a GMP environment.

• LIMS stands for Laboratory Information Management System, used for managing laboratory data and workflows.

• ALCOA+ principles ensure data integrity in regulated environments, including GMP.

• Working in a GMP environment involves following strict guidelines to ensure product quality and safety.

• For example, in a pharmaceutical company, adherence to GMP ensures that medications are produced consistently and meet quali...read more

Validation is done by following guidelines and standards to ensure accuracy and reliability of data.

• Follow industry standards and best practices for validation

• Use validation tools and software to automate the process

• Perform manual checks and reviews to ensure data accuracy

• Document validation procedures and results for future reference

• Regularly update validation processes to adapt to changing requirements

When the product analysis result is out of limit, I take immediate action to investigate the issue and implement corrective measures.

• Identify the cause of the out-of-limit result

• Evaluate the impact on product quality and safety

• Implement corrective actions to bring the product within acceptable limits

• Communicate the findings and actions to relevant stakeholders

• Monitor the effectiveness of the corrective measures

I have handled a variety of instruments including cash registers, computer software, and office equipment.

• Cash registers

• Computer software

• Office equipment

The best technique can be determined by evaluating its effectiveness, efficiency, feasibility, and alignment with goals.

• Assess the success rate of the technique in achieving desired outcomes.

• Consider the cost and resources required to implement the technique.

• Evaluate the practicality and ease of implementation of the technique.

• Ensure that the technique aligns with the overall goals and objectives of the organization.

• Seek feedback from stakeholders who have experience with the...read more

Spray gun distance in coating machine can be handled by adjusting the distance between the gun and the surface being coated.

• Maintain a consistent distance between the gun and the surface being coated.

• Adjust the distance based on the type of coating and the surface being coated.

• Practice and experience can help in determining the optimal distance.

• Regularly check and adjust the distance during the coating process.

• Use tools like laser distance meters to ensure accuracy.

To develop RS method on HPLC, one must consider factors like column selection, mobile phase composition, and detection wavelength.

• Select an appropriate column based on the properties of the analytes being separated.

• Optimize the mobile phase composition to achieve good resolution and peak shape.

• Choose the appropriate detection wavelength for optimal sensitivity and selectivity.

• Validate the method by testing for linearity, accuracy, precision, and robustness.

• Consider factors li...read more

MACO value is the Minimum Acceptable Compliance Objective, used to determine the minimum level of compliance required in a system.

• MACO value is calculated based on the specific requirements and regulations of the system or industry.

• It is typically determined by assessing the potential risks and consequences of non-compliance.

• MACO value helps set a baseline for acceptable compliance levels and guides decision-making processes.

• Example: In a manufacturing plant, the MACO value f...read more

There are three types of process validation batches.

• The three types of process validation batches are prospective validation, concurrent validation, and retrospective validation.

• Prospective validation involves validating a process before it is put into routine use.

• Concurrent validation involves validating a process while it is in routine use.

• Retrospective validation involves validating a process that has been in routine use based on historical data.

• Each type of validation bat...read more

I will investigate the cause of the colour variation and take appropriate actions to rectify it.

• Conduct a thorough investigation to determine the cause of the colour variation

• Identify if the issue is due to a faulty product or a manufacturing error

• Take corrective actions to rectify the issue, such as adjusting the manufacturing process or replacing the faulty product

• Ensure that quality control measures are in place to prevent future occurrences

To ensure sterility after autoclave sterilization, proper handling and storage techniques must be followed.

• Ensure proper loading of items in autoclave to allow for adequate steam penetration

• Use appropriate sterilization parameters such as time, temperature, and pressure

• Allow items to cool down completely before handling to prevent contamination

• Store sterilized items in a clean and dry environment to maintain sterility

• Regularly monitor and validate autoclave performance throug...read more

Yes, I have experience in dissolution development.

• I have experience in designing dissolution methods for pharmaceutical products.

• I have conducted dissolution studies to assess drug release profiles.

• I have optimized dissolution conditions to meet regulatory requirements.

• I have analyzed dissolution data to ensure product quality and consistency.

I handle a variety of machines in coating, including spray guns, rollers, and dip tanks.

• I am experienced in using spray guns to apply coatings to surfaces.

• I am skilled in using rollers to apply coatings to larger surfaces.

• I am familiar with dip tanks and how to use them to coat objects.

• I have experience with other coating machines such as electrostatic sprayers and powder coating guns.

Zeta potential is the electrical charge at the slipping plane of a particle in a dispersion.

• Zeta potential is a key parameter in colloidal systems, influencing stability and interactions between particles.

• It is measured in millivolts (mV) and can be positive, negative, or zero.

• Higher zeta potential values indicate greater repulsion between particles, leading to increased stability.

• For example, in pharmaceuticals, zeta potential is important for controlling the stability of dr...read more

I have extensive knowledge of FDA audits and have faced 5 audits in my previous role.

• I have a deep understanding of FDA regulations and guidelines.

• I am familiar with the audit process and requirements.

• I have successfully managed and prepared for 5 FDA audits in my previous role.

• I have experience in ensuring compliance with FDA regulations and addressing any audit findings.

• I have implemented corrective actions based on audit recommendations to improve processes and maintain co...read more

Basic policies to take care when there is an FDA

• Ensure compliance with FDA regulations and guidelines

• Implement proper documentation and record-keeping practices

• Establish quality control measures to ensure product safety and efficacy

• Train employees on FDA regulations and procedures

• Maintain a system for reporting adverse events or product defects

• Stay updated on FDA updates and changes in regulations

• Collaborate with FDA inspectors during inspections or audits

• Respond promptly and...read more

Preliminary investigation in OOS refers to the initial inquiry conducted to identify the potential causes of an Out-of-Specification result.

• Preliminary investigation is a crucial step in determining the root cause of an OOS result.

• It involves gathering relevant information, reviewing documentation, and conducting initial tests or analyses.

• The purpose is to identify potential factors that may have contributed to the OOS result.

• Examples of preliminary investigation activities i...read more

Handling a medi fill investigation involves thorough analysis, documentation, and corrective actions.

• Start by gathering all relevant information and documentation related to the medi fill incident.

• Conduct a detailed analysis to identify the root cause of the issue.

• Document all findings, including any deviations from standard procedures or protocols.

• Implement corrective actions to prevent similar incidents in the future.

• Ensure proper communication and collaboration with all st...read more

Critical surface sampling locations for a filling line are key areas where contamination is most likely to occur.

• Critical surface sampling locations include the filling nozzle, conveyor belts, capping machine, and packaging area.

• Other important areas to sample are the product contact surfaces, such as the inside of the filling machine and the product containers.

• Regularly sampling these locations helps ensure product quality and safety.

• Examples of critical surface sampling loc...read more

A straightified sample is a representative subset of a larger dataset that has been organized in a linear or sequential manner.

• Straightified sampling involves selecting data points in a systematic order.

• It is often used in time series analysis or when data needs to be processed in a specific order.

• For example, in analyzing stock market data, a straightified sample may involve selecting data points at regular intervals over a specific time period.

The surface of the glove port should be cleaned and disinfected before use.

• Clean the surface of the glove port using a suitable cleaning agent

• Disinfect the surface with a disinfectant solution to kill any remaining bacteria or viruses

• Ensure the surface is completely dry before use to prevent contamination

The critical parameter in FBE is the film build thickness, which affects the performance and durability of the coating.

• Film build thickness is crucial for achieving the desired level of protection

• It impacts the coating's adhesion, flexibility, and overall performance

• Proper film build thickness ensures long-term durability and corrosion resistance

• Measuring film build thickness accurately is essential for quality control

• Examples: Too thin film build may result in inadequate pro...read more

The limit of passive air monitoring varies in different grade areas. The endotoxin limit of WFI water is determined by regulatory guidelines.

• The limit of passive air monitoring in grade A, B, C, D areas is determined by the classification of these areas according to regulatory guidelines.

• Grade A areas have the strictest limits for particulate and microbial contamination, while grade D areas have the least stringent limits.

• For example, in a grade A area, the limit for particul...read more

Biological indicators are used to monitor sterilization processes. Types include spore strips, spore suspensions, and self-contained biological indicators.

• Spore strips: paper strips with spores that are placed in the sterilization process and then incubated to check for growth

• Spore suspensions: liquid suspensions containing spores that are used to test sterilization processes

• Self-contained biological indicators: complete units that contain spores and growth medium for monitor...read more

Yes

• I have extensive experience in FDA activities and audit preparations.

• I have successfully managed FDA inspections and audits, ensuring compliance with regulations and guidelines.

• I have developed and implemented standard operating procedures (SOPs) to ensure adherence to FDA requirements.

• I have conducted internal audits to identify areas of improvement and implemented corrective actions.

• I have trained staff on FDA regulations and guidelines to ensure understanding and compli...read more

HS gun stands for high-speed gun and LD gun stands for low-dose gun in the context of industrial operations.

• HS gun refers to a high-speed gun used for rapid and efficient operations.

• LD gun refers to a low-dose gun used for operations requiring less power or intensity.

• Examples include high-speed guns used in manufacturing processes and low-dose guns used in radiation therapy.

Autoclave qualification guidelines ensure proper functioning and validation of autoclaves.

• Follow regulatory guidelines such as FDA, ISO, and GMP requirements

• Perform initial qualification with installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)

• Regularly calibrate and validate autoclave parameters like temperature, pressure, and time

• Document all qualification activities and results for traceability and compliance

• Train personnel on...read more

Method validation is confirming that a method is suitable for its intended use, while method development is creating a new method.

• Method validation ensures that a method is reliable, accurate, and consistent for its intended use.

• Method development involves creating a new method from scratch or modifying an existing one to improve its performance.

• Validation is a necessary step before a method can be used for routine testing, while development is done to improve the method's pe...read more

Out of trends can be calculated by analyzing data points and identifying deviations from expected trends.

• Collect data points over a period of time

• Plot the data points on a graph

• Identify the expected trend based on historical data

• Analyze the data points to identify any deviations from the expected trend

• Calculate the percentage of data points that fall outside the expected trend

• Investigate the reasons for the deviations and take corrective actions

Investigated a customer complaint regarding product quality issues

• Conducted interviews with production staff to gather information

• Analyzed production records and quality control data

• Identified root cause of the quality issues as a supplier error

• Implemented corrective actions to prevent future occurrences

CAPA stands for Corrective and Preventive Action. It is a systematic approach to identify, investigate, and resolve quality issues.

• CAPA is a quality management process used to address and correct nonconformities and prevent their recurrence.

• It involves identifying the root cause of a problem, implementing corrective actions to address the immediate issue, and preventive actions to prevent future occurrences.

• CAPA typically follows a defined process flow, including problem iden...read more

Process non conformance is when a process does not meet the required standards or specifications.

• It occurs when a process fails to meet the established requirements or specifications

• It can lead to defects, delays, and increased costs

• It is important to identify and address process non conformance to ensure quality and efficiency

• Examples include a manufacturing process that produces defective products or a software development process that fails to meet user requirements

5 Why analysis is a problem-solving technique used to identify the root cause of a problem by asking 'why' five times.

• It involves asking 'why' five times to get to the root cause of a problem.

• It helps to identify the underlying cause of a problem rather than just addressing the symptoms.

• It is often used in quality control and process improvement.

• Example: Why did the machine stop working? Because the motor burned out. Why did the motor burn out? Because it overheated. Why did ...read more

Yes, this place is suitable for me due to its advanced technology, clean environment, and experienced team.

• Advanced technology in parenteral production

• Clean and organized work environment

• Experienced and knowledgeable team members

• Opportunities for growth and development

• Positive company culture and values

Maintenance processes include preventive, corrective, predictive, and condition-based maintenance.

• Preventive maintenance involves scheduled inspections and repairs to prevent equipment failure.

• Corrective maintenance is performed after a failure has occurred.

• Predictive maintenance uses data analysis to predict when maintenance is needed.

• Condition-based maintenance involves monitoring equipment to detect signs of wear or damage.

• Maintenance processes can also be categorized as r...read more

I read industry-specific guidelines, company policies, and management best practices.

• Industry-specific guidelines such as ISO standards or regulatory requirements

• Company policies and procedures for consistency and compliance

• Management best practices for effective leadership and team development