Apotex Research
Abhishek Glass Industries Interview Questions and Answers
Q1. Quality management is end reports
Quality management is not just about end reports, but a continuous process of ensuring product quality and compliance.
Quality management involves establishing and maintaining quality systems and processes
It includes monitoring and controlling all aspects of product development, manufacturing, and distribution
Quality management also involves continuous improvement and corrective actions
End reports are just one aspect of quality management, and should be used to inform and impr...read more
Q2. Qualification process for AHU system. Handling of equipment
Qualification process for AHU system involves handling of equipment to ensure compliance with standards.
Qualification process involves testing and verifying the performance of AHU system.
Equipment handling should follow standard operating procedures to prevent contamination.
Documentation of the qualification process and equipment handling is necessary for compliance.
Examples of equipment handling include cleaning, calibration, and maintenance.
Qualification process should be p...read more
Q3. QSAR tool prediction for surrogate how.l to analyse data
QSAR tools use mathematical models to predict the toxicity of chemicals based on their structure.
Use QSAR tools to input chemical structure data and predict toxicity levels
Analyze the output data to understand the predicted toxicity of the surrogate
Compare the predicted toxicity with experimental data for validation
Adjust parameters in the QSAR model to improve accuracy if needed
Q4. Separation techniques for QC
Separation techniques are used in quality control to separate and analyze different components of a sample.
Separation techniques are used to isolate and identify individual components in a mixture or sample.
Common separation techniques include chromatography, distillation, filtration, and centrifugation.
Chromatography separates components based on their different affinities for a stationary phase and a mobile phase.
Distillation separates components based on their different bo...read more
Q5. whatt is GCP and principles
GCP stands for Good Clinical Practice. It is a set of ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.
GCP ensures the safety and well-being of trial participants
It ensures the reliability and credibility of trial results
It requires informed consent from participants
It mandates proper documentation and record-keeping
It requires monitoring and auditing of trials
It emphasizes the importance of confidentiality and data ...read more
Q6. FDA guidelines for Toxicology study conduct
FDA guidelines outline the requirements for conducting toxicology studies.
Toxicology studies must follow Good Laboratory Practices (GLP) regulations.
Studies must be designed to identify potential adverse effects of the test substance.
The study design should include appropriate controls and endpoints.
The study should be conducted using relevant animal models and doses.
The results should be reported accurately and objectively.
The study report should include a summary of the fin...read more
Q7. ICH guidelines for Toxicology
ICH guidelines provide recommendations for the conduct of toxicology studies in drug development.
ICH guidelines aim to ensure the safety of human subjects in clinical trials.
They provide guidance on the design, conduct, and reporting of toxicology studies.
ICH guidelines cover topics such as genotoxicity, carcinogenicity, reproductive toxicity, and immunotoxicity.
Examples of ICH guidelines include S1(R2) for rodent carcinogenicity studies and M3(R2) for nonclinical safety stud...read more
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