20+ SS Solution | Durgapur Interview Questions and Answers

I have extensive USFDA audit exposure and have implemented various compliance measures.

• I have been a part of multiple USFDA audits and have experience in handling them.

• I have implemented compliance measures such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

• I have also ensured compliance with regulations such as 21 CFR Part 11 and 21 CFR Part 820.

• In my previous role, I led a team that successfully passed a USFDA audi...read more

Handled deviations during batch execution by identifying root cause, implementing corrective actions, and documenting the process.

• Identified root cause of deviation

• Implemented corrective actions to prevent future deviations

• Documented the deviation and corrective actions taken

• Communicated the deviation and corrective actions to relevant stakeholders

Regular maintenance, proper installation, and using high-quality components can reduce breakdown in machines.

• Regular maintenance can prevent wear and tear on machines

• Proper installation ensures that machines are set up correctly and reduces the risk of malfunctions

• Using high-quality components can increase the lifespan of machines and reduce the risk of breakdowns

• Implementing safety measures can prevent accidents that can damage machines

• Monitoring machines for signs of wear a...read more

CAPA stands for Corrective and Preventive Action. It is a process used to investigate and address complaints in the current market.

• CAPA is a systematic approach to identifying the root cause of a problem and taking corrective and preventive actions to prevent it from recurring.

• It involves investigating the complaint, identifying the cause, implementing corrective actions, and monitoring the effectiveness of those actions.

• Examples of CAPA include implementing new procedures, t...read more

Yes, I have drafted market complaint investigations.

• I have experience drafting market complaint investigations for various clients.

• I am familiar with the regulatory requirements and guidelines for such investigations.

• One example of a market complaint investigation I drafted involved a product recall due to safety concerns.

• I also worked on a market complaint investigation related to false advertising claims made by a competitor.

• My investigations have always been thorough and w...read more

Equipment sub class and classification vary according to unit operations.

• Equipment sub classes include mixing, separation, heat transfer, and reaction equipment.

• Mixing equipment includes agitators, blenders, and mixers.

• Separation equipment includes centrifuges, filters, and screens.

• Heat transfer equipment includes heat exchangers and boilers.

• Reaction equipment includes reactors and fermenters.

• Classification is based on the type of unit operation, such as distillation or cryst...read more

Changes made while transferring a product from same scale depend on various factors.

• The level of changes depends on the type of product being transferred.

• The level of changes also depends on the scale of transfer.

• Changes can be made in packaging, labeling, and formulation.

• Changes should be made while keeping in mind the regulatory requirements.

• Changes should be made while ensuring the quality and safety of the product.

OEE stands for Overall Equipment Effectiveness. It is a metric used to measure manufacturing productivity.

• OEE takes into account three factors: availability, performance, and quality.

• Availability measures the percentage of time the equipment is available for production.

• Performance measures the speed at which the equipment is running compared to its maximum speed.

• Quality measures the percentage of good quality products produced by the equipment.

• OEE is calculated by multiplying...read more

Risk assessment requires careful consideration of potential hazards and their likelihood of occurrence.

• Identify potential hazards

• Assess the likelihood of occurrence

• Evaluate the potential consequences

• Consider the effectiveness of existing controls

• Determine the level of risk

• Develop and implement risk management strategies

CAPA is effective in identifying and correcting root causes of problems to prevent recurrence.

• CAPA stands for Corrective and Preventive Action.

• It is a systematic approach to problem-solving and quality improvement.

• CAPA helps to identify the root cause of a problem and take corrective action to prevent recurrence.

• It also helps to prevent potential problems by taking preventive action.

• Effective CAPA implementation can lead to improved product quality, customer satisfaction, and...read more

I handle shift operations by ensuring proper communication, delegation of tasks, and monitoring performance.

• Maintain open communication with team members

• Delegate tasks based on individual strengths and workload

• Monitor performance and provide feedback for improvement

• Ensure proper handover between shifts

• Address any issues or concerns promptly

• Maintain a positive and productive work environment

Scale up factors are important during site transfer to ensure successful implementation.

• Scale up factors refer to the considerations and adjustments needed when transferring a process or operation from one site to another.

• Factors to consider include equipment capacity, process efficiency, resource availability, and regulatory compliance.

• Examples of scale up factors include ensuring the new site has adequate space and infrastructure to accommodate the process, verifying that e...read more

Qualification stages can be categorized into three types.

• Theoretical qualification stage

• Practical qualification stage

• Final qualification stage

OSD stands for Oral Solid Dosage. It involves the breakdown and maintenance process of solid medications.

• OSD refers to solid medications like tablets and capsules.

• Breakdown process involves disintegration of the tablet or capsule in the gastrointestinal tract.

• Maintenance process ensures the stability and effectiveness of the medication.

• Examples include tablets that dissolve in the stomach to release the active ingredient.

The manufacturing process involves multiple steps from raw material procurement to final product assembly.

• Raw material procurement

• Quality control checks

• Production line assembly

• Packaging and labeling

• Final product inspection

Analytical method validation is the process of demonstrating that an analytical method is suitable for its intended use.

• It involves testing the accuracy, precision, specificity, and robustness of the method.

• Validation is necessary to ensure that the results obtained from the method are reliable and reproducible.

• It is a requirement for regulatory compliance in industries such as pharmaceuticals and food.

• Examples of analytical methods that require validation include HPLC, GC, a...read more

CPP stands for Current Good Manufacturing Practice and CQA stands for Critical Quality Attributes.

• CPP refers to the set of guidelines and regulations that ensure the quality and safety of pharmaceutical products during their manufacturing process.

• CQA refers to the specific characteristics of a product that are critical to its quality and must be monitored and controlled during the manufacturing process.

• CPP and CQA are both important concepts in the pharmaceutical industry to ...read more

Instruments work based on specific principles like measuring, detecting, or analyzing physical quantities.

• Instruments operate based on physical principles such as electromagnetism, optics, or mechanics.

• They convert physical quantities into measurable signals or data.

• Examples include thermometers measuring temperature, spectrophotometers analyzing light absorption, and voltmeters detecting voltage.

• Instruments may use sensors, transducers, or detectors to capture data and displ...read more

I'm sorry, I don't understand the question.

• Please clarify the question.

• I'm not sure what you're asking.

• Can you please provide more context?

• I don't have enough information to answer this question.

Troubleshooting in method validation involves identifying and resolving issues that arise during the validation process.

• Identify the source of the problem

• Review the validation protocol and ensure it is being followed correctly

• Check equipment and reagents for accuracy and precision

• Evaluate data and determine if it meets acceptance criteria

• Make necessary adjustments and revalidate as needed

Warehouse management requires efficient planning, organization, and communication.

• Create a system for inventory management and tracking

• Ensure safety protocols are in place and followed

• Train and supervise staff to maintain cleanliness and organization

• Communicate effectively with other departments to ensure timely delivery of goods

• Regularly review and analyze warehouse operations to identify areas for improvement