10+ Pulkeshin Storytellers Interview Questions and Answers

Calibrating disintegration and friability test apparatus ensures accurate measurement of tablet quality and performance.

• 1. Disintegration Test Apparatus Calibration: Use standard tablets to verify the apparatus meets specified disintegration times.

• 2. Ensure the water temperature is maintained at 37°C ± 2°C during testing.

• 3. Check the basket and disk assembly for proper alignment and functionality.

• 4. Friability Test Apparatus Calibration: Use a standard sample (e.g., a specifi...read more

Stratified sampling is a method that divides a population into subgroups to ensure representation in the sample.

• In stratified sampling, the population is divided into distinct subgroups (strata) based on specific characteristics.

• Each stratum is sampled independently, ensuring that all subgroups are represented in the final sample.

• For example, in a study on student performance, strata could be based on grade levels (freshman, sophomore, etc.).

• This method reduces sampling bias ...read more

Sampling points for octagonal and con blenders ensure uniformity and quality in mixing processes.

• Octagonal blenders typically require 5-7 sampling points for effective analysis.

• Con blenders may need 3-5 sampling points depending on the batch size.

• Sampling points should be evenly distributed to capture variations in the blend.

• For example, in a 100 kg batch, sampling from different sections can provide insights into homogeneity.

Stratified sampling involves collecting samples from distinct subgroups to ensure representation.

• Samples are collected from each stratum based on its proportion in the population.

• For example, if a population has 60% females and 40% males, samples should reflect this ratio.

• The number of samples from each stratum can vary depending on the study design.

• Stratified sampling helps improve the accuracy and reliability of results.

21 CFR guidelines regulate food and drug safety in the U.S., including sampling protocols for compliance.

• 21 CFR stands for Title 21 of the Code of Federal Regulations, which governs food and drugs in the U.S.

• Key parts include 21 CFR Part 210 and 211, which outline Good Manufacturing Practices (GMP).

• Sampling guidelines can be found in 21 CFR Part 58, which covers Good Laboratory Practices (GLP).

• For example, 21 CFR 211.165 specifies the need for sampling and testing of drug pro...read more

Data integrity ensures accuracy and consistency of data over its lifecycle, with ALCOA and ALCOA+ emphasizing data quality principles.

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

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, which are key principles for data integrity.

• ALCOA+ expands on ALCOA by adding additional principles like Complete, Consistent, Enduring, and Available.

• For example, ...read more

21 CFR Part 11 ensures the integrity and security of electronic records in the pharmaceutical industry.

• Establishes criteria for electronic records and signatures to be considered trustworthy.

• Ensures data integrity by requiring audit trails for electronic records.

• Facilitates compliance with FDA regulations, enhancing product safety and efficacy.

• Example: A pharmaceutical company must validate its electronic systems to ensure data accuracy.

• Promotes the use of electronic systems ...read more

Temperature affects the separation and retention time of analytes in HPLC analysis.

• Higher temperature can decrease retention time and resolution.

• Lower temperature can increase retention time and resolution.

• Temperature should be controlled and kept constant during analysis.

• Column temperature can affect the selectivity of the stationary phase.

• Temperature can also affect the viscosity of the mobile phase and the solubility of the analytes.

About refers to an approximate amount or quantity.

• About means approximately or roughly.

• It is used when an exact amount is not known or specified.

• For example, 'I need about 2 cups of flour for this recipe.'

Peak purity is a measure of the homogeneity of a chromatographic peak, indicating the presence of impurities or co-eluting compounds.

• Peak purity is determined by comparing the spectra of the peak at different wavelengths.

• A pure peak will have a consistent spectrum across different wavelengths, while impurities will show variations.

• Peak purity analysis is commonly used in pharmaceutical and analytical chemistry to ensure the quality and purity of drugs and compounds.

• It can be ...read more

Noise is unwanted or unpleasant sound that can cause disturbance or harm to human health.

• Noise can be caused by various sources such as traffic, construction, industrial machinery, and loud music.

• Exposure to high levels of noise can lead to hearing loss, stress, and other health problems.

• Noise pollution is a growing concern in urban areas and can have negative impacts on both humans and wildlife.

• Noise can be measured in decibels (dB) and the safe exposure limit for humans is ...read more

21 CFR part 11 is a regulation by the FDA for electronic records and signatures. Data integrity refers to the accuracy and consistency of data. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. Cleaning validation is the process of ensuring that cleaning procedures effectively remove residues. Handling deviations involves documenting, investigating, and resolving any deviations from standard procedures. CAPA stands for Corrective and Preventive ...read more

LOQ and LOD values are used in analytical chemistry to determine the lowest concentration of a substance that can be reliably detected and quantified.

• LOQ stands for Limit of Quantification and is the lowest concentration of a substance that can be reliably quantified.

• LOD stands for Limit of Detection and is the lowest concentration of a substance that can be reliably detected.

• LOD is usually higher than LOQ.

• LOQ and LOD are important parameters in analytical chemistry and are u...read more