Acme Generics LLP
10+ TruConnect Solutions Interview Questions and Answers
Q1. What are the steps involved in calibrating the disintegration test apparatus and the friability test apparatus?
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
Q2. What is stratified sampling, how is it performed, and what is its significance?
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
Q3. What are the 21 CFR guidelines, and which guidelines are used for sampling?
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
Q4. What is the principle of data integrity, and what do ALCOA and ALCOA+ represent?
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
Q5. What is the significance of 21 CFR Part 11 in the pharmaceutical industry?
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
Q6. What is the required number of sampling points for octagonal and con blenders?
Q7. How many samples are collected during the compression stage for stratified sampling?
Q8. What is the effect of temperature on HPLC analysis?
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.
Q9. What do you mean by About. Like about 20mg?
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.'
Q10. What is peak purity.
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
Q11. What is noise.
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
Q12. What is 21 CFR part 11 ? What is data integrity and ALCOA? What is cleaning validation? How to handle deviation? What is CAPA ? tell me about investigation tools of incidents?
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
Q13. Define LOQ and LOD value?
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
Q14. Guidline for qms
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