Ipca Laboratories Interview Questions and Answers

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 ...read more

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...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 ...read more

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 spe...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 deter...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 comple...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 on...read more