10+ Il&fs Tamil Nadu Power Company Interview Questions and Answers

Answering questions related to instruments handling, software usage, calibration, and AMC.

• Handled various instruments such as HPLC, GC, KF, etc.

• Worked with software like Empower, Chromeleon, etc.

• Calibration of instruments involves checking and adjusting the accuracy of the instrument using standard solutions.

• AMC stands for Annual Maintenance Contract, which is a service agreement between the instrument manufacturer and the user for regular maintenance and repair of the instru...read more

Guidelines for validation of autoclave and tunnel

• Autoclave validation should follow guidelines from ISO 17665-1 and PDA Technical Report No. 1

• Tunnel validation should follow guidelines from PDA Technical Report No. 39

• Validation should include physical and biological indicators

• Physical indicators include temperature, pressure, and time

• Biological indicators include spore strips or ampoules

• Validation should be performed initially and periodically thereafter

• Validation should be p...read more

The washing machine challenge test and validation involves testing the washing machine's performance under various conditions.

• Test the washing machine's ability to clean clothes effectively

• Validate the washing machine's ability to handle different load sizes

• Check the washing machine's energy efficiency and water consumption

• Ensure the washing machine's durability and reliability

• Conduct safety tests to ensure the washing machine meets regulatory standards

Critical parameters of manufacturing are the key factors that affect the quality and consistency of the final product.

• Critical parameters are specific to each manufacturing process and product.

• They include factors such as temperature, pressure, humidity, and time.

• Monitoring and controlling critical parameters is essential to ensure product quality and consistency.

• Examples of critical parameters in pharmaceutical manufacturing include particle size, pH, and sterility.

• In food m...read more

WFI is water for injection while purified water is water that has been purified to remove impurities.

• WFI is used for parenteral preparations while purified water is used for non-parenteral preparations.

• WFI is produced by distillation or reverse osmosis while purified water is produced by various methods such as ion exchange, filtration, and distillation.

• WFI has a higher purity level than purified water.

• WFI is required to meet specific compendial standards while purified water...read more

APQR Preparation requirements include data collection, analysis, and documentation of product quality review.

• Collecting data on product quality and performance

• Analyzing the data to identify trends and areas for improvement

• Documenting the findings and actions taken in a report

• Ensuring compliance with regulatory requirements

• Involving cross-functional teams in the review process

• Regularly reviewing and updating the APQR as needed

Validation ensures that a process or system meets the intended requirements and specifications, while qualification ensures that the equipment or system is installed and operates correctly.

• Validation is about ensuring that the process or system meets the intended requirements and specifications.

• Qualification is about ensuring that the equipment or system is installed and operates correctly.

• Validation is focused on the end result, while qualification is focused on the process....read more

Two guidelines for autoclave validation are proper documentation and regular calibration.

• Documentation should include validation protocols, equipment maintenance records, and training records.

• Calibration should be performed regularly to ensure accurate temperature and pressure readings.

• Validation should be performed using biological indicators and physical measurements.

• Validation should be performed after any major repairs or changes to the autoclave.

• Validation should be perf...read more

Buffers are solutions that resist changes in pH when small amounts of acid or base are added.

• Buffers are typically made up of a weak acid and its conjugate base, or a weak base and its conjugate acid

• Common examples of buffers include acetic acid and acetate ion, or ammonia and ammonium ion

• Buffers are important in maintaining stable pH levels in biological systems

Tailing factor is a measure of the efficiency of a chromatographic column.

• Tailing factor is calculated as the distance between the peak maximum and the baseline divided by twice the standard deviation of the peak.

• A tailing factor of 1 indicates a symmetrical peak, while values greater than 1 indicate tailing and less than 1 indicate fronting.

• Tailing factor is important in chromatography to assess the quality of separation and peak shape.

F1 and F2 criteria are used for comparative dissolution study with innovator sample.

• F1 criteria: 85% of drug should dissolve in 30 minutes in pH 1.2 buffer solution.

• F2 criteria: Difference factor between innovator and generic sample should be less than 15.

• Comparative dissolution study is done to ensure bioequivalence of generic drug with innovator drug.

• Dissolution testing is important for drug release and absorption in the body.

Accuracy is the degree of closeness of a measured or calculated quantity to its actual (true) value.

• Accuracy is a measure of how close a measurement is to the true value.

• It is important in various fields such as science, engineering, and statistics.

• For example, in shooting sports, accuracy refers to how close a shot is to the target center.

• In data analysis, accuracy is used to evaluate the performance of a predictive model.

Robustness refers to the ability of a system to remain stable and functional under varying conditions or stress.

• Robustness is the ability of a system to handle unexpected inputs or disturbances without crashing or failing.

• It involves designing systems to be resilient and able to recover from errors or failures.

• For example, a robust computer program should be able to handle invalid user inputs without crashing.

• In engineering, robustness can refer to the ability of a structure ...read more

CPP stands for Certified Pharmaceutical Professional and CQA stands for Certified Quality Auditor.

• CPP is a certification for professionals working in the pharmaceutical industry, demonstrating their knowledge and expertise in various areas such as drug development, manufacturing, and quality control.

• CQA is a certification for professionals involved in quality assurance and auditing, ensuring that products, processes, and systems meet the required standards and regulations.

• CPP...read more

ALCOA principle is a guideline for ensuring data integrity in regulated industries, emphasizing data should be attributable, legible, contemporaneous, original, and accurate.

• Attributable - Data should be traceable to its source.

• Legible - Data should be clear and easy to read.

• Contemporaneous - Data should be recorded at the time of observation.

• Original - Data should be the first recording of the information.

• Accurate - Data should be error-free and true to the actual observatio...read more

GMP in pharma stands for Good Manufacturing Practice, which are guidelines and regulations ensuring the quality and safety of pharmaceutical products.

• GMP regulations are enforced by regulatory agencies to ensure pharmaceutical products are consistently produced and controlled according to quality standards.

• These standards cover all aspects of production, including the facilities, equipment, personnel, and processes.

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

Pyrogen is a substance that causes fever while sterile means free from living microorganisms.

• Pyrogen is a fever-causing substance that can be found in contaminated medical equipment or drugs.

• Sterile refers to a state of being free from living microorganisms, including bacteria, viruses, and fungi.

• Sterilization is a process that eliminates all forms of microbial life, including spores.

• Pyrogen testing is done to ensure that medical equipment and drugs are free from fever-causin...read more