Naxpar Pharma Senior Manager Quality Control Interview Questions and Answers

Q1. Define the principle of tlc
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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
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Q2. Disintegration and dissolution difference
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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
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Q1. Based on reviews, how to review, preparation documentation
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Q2. How to reviews of pvr& pqrs
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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
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Q1. Your salary expectation
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Q1. Questions about your profile mentioned in your resume
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Q1. TGA Guidelines Sterilization QMS
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Q2. All mentioned in CV
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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
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Q2. What are the ypes of Process validation?
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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
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Q3. How you are doing Audit trail?
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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
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Q4. Asking about APQR
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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
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Q1. Purified water specification?
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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
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Q2. Purified water specification of Microbal
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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
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Q3. USP chapters of Microbial tesing of API and water
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Q4. Growth Pramotion tests
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Q5. Horizontal Autoclave validation
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Q6. Types of validation
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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
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Q1. Tell me about your self
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Q2. Are you willing to shift Vizag
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Q3. Salary discussion
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Q1. Shop floor activities in Production, From Dispensing to packing
Ans. 
Shop floor activities in production involve dispensing, manufacturing, packaging, and quality control.
• Dispensing of raw materials

• Manufacturing of products

• Packaging of finished goods

• Quality control checks throughout the process

• Cleaning and maintenance of equipment

• Documentation of all activities

• Training of personnel

• Adherence to safety protocols
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Q2. Line clearance details, End point in granulation, critical points in RMG.
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Q3. Compression machine parameters , and defects identify
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Compression machine parameters and defects identification
• Compression machine parameters include force, speed, and displacement

• Defects can be identified through visual inspection and testing

• Common defects include cracks, voids, and delamination

• Testing methods include ultrasonic testing and dye penetrant inspection
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