Navesta Pharmaceuticals Quality Control Head Interview Questions and Answers

Q1. Define the principle of tlc
Ans. 
TLC stands for Thin Layer Chromatography, a technique used to separate and analyze mixtures of chemicals.
• TLC involves a stationary phase (thin layer of adsorbent material) and a mobile phase (solvent).

• The sample mixture is spotted on the TLC plate and the plate is placed in a developing chamber with the mobile phase.

• Different components of the mixture move at different rates on the plate, allowing for separation and id...read more
Answered by AI
Add your answer
Q2. Disintegration and dissolution difference
Ans. 
Disintegration is the breakdown of a solid dosage form into smaller particles, while dissolution is the process by which a solid substance dissolves in a liquid.
• Disintegration is a physical process, while dissolution is a chemical process.

• Disintegration involves the breaking down of a tablet or capsule into smaller pieces, while dissolution involves the solubilization of the active ingredient.

• Disintegration testing is ...read more
Answered by AI
Add your answer

Q1. Discuss about your project?
Add your answer

Q1. Discuss about subject related like disease and drugs
Add your answer
Q2. Discuss about Quality management system and Data integrity
Add your answer

Q1. Based on reviews, how to review, preparation documentation
Add your answer
Q2. How to reviews of pvr& pqrs
Ans. 
Reviews of PVR and PQRS can be conducted through a systematic process involving data analysis and evaluation.
• Collect and analyze data related to PVR and PQRS

• Evaluate the performance and quality based on established criteria

• Identify areas of improvement and develop action plans

• Implement changes and monitor the impact

• Continuously review and update the process to ensure ongoing quality assurance
Answered by AI
Add your answer

Q1. Your salary expectation
Add your answer

Q1. Questions about your profile mentioned in your resume
Add your answer

Q1. TGA Guidelines Sterilization QMS
Add your answer
Q2. All mentioned in CV
Add your answer

Numericals

Q1. Tell me about change Control? And give me One Example?
Ans. 
Change control is a process used to manage and document changes to a system or process.
• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more
Answered by AI
Add your answer
Q2. What are the ypes of Process validation?
Ans. 
Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.
• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more
Answered by AI
Add your answer
Q3. How you are doing Audit trail?
Ans. 
Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.
• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more
Answered by AI
Add your answer
Q4. Asking about APQR
Add your answer
Q5. Are you interested in Microbiology analytical review?
Ans. 
Yes, I am interested in Microbiology analytical review.
• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more
Answered by AI
Add your answer

Q1. Purified water specification?
Ans. 
Purified water specification refers to the set of requirements and standards that purified water must meet.
• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more
Answered by AI
Add your answer
Q2. Purified water specification of Microbal
Ans. 
The purified water specification for microbial quality assurance.
• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more
Answered by AI
Add your answer
Q3. USP chapters of Microbial tesing of API and water
Add your answer
Q4. Growth Pramotion tests
Add your answer
Q5. Horizontal Autoclave validation
Add your answer
Q6. Types of validation
Ans. 
Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.
• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more
Answered by AI
Add your answer

Q1. Tell me about your self
Add your answer
Q2. Are you willing to shift Vizag
Add your answer
Q3. Salary discussion
Add your answer