Hikal Panel Officer Interview Questions and Answers

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?
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
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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?
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
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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
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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. Discuss about your project?
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Q1. Discuss about subject related like disease and drugs
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Q2. Discuss about Quality management system and Data integrity
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Q1. Tell me about yourself
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Q2. Technical question For regarding to job profile only
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Q3. Previous experience related questions
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Q4. Pharma area cleaning and batch charging
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Q5. Product change over related
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Q1. What is the role of Medicine in future.
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Q2. Where to see this industry in Pharma role to Future Aspects?
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Discuss about people healthy life

Q1. How to turn a hollow shaft at lathe it's ID and OD
Ans. 
To turn a hollow shaft at lathe, use a chuck and steady rest to support the workpiece and turn the ID and OD separately.
• Mount the hollow shaft on the lathe using a chuck

• Use a steady rest to support the workpiece and prevent it from bending or vibrating

• Turn the ID of the shaft using a boring bar

• Turn the OD of the shaft using a cutting tool

• Measure the dimensions of the shaft using a micrometer to ensure accuracy
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Q2. How size of driil used for M4 tapping
Ans. 
The size of drill used for M4 tapping is 3.3 mm.
• The recommended drill size for M4 tapping is 3.3 mm.

• The drill size may vary depending on the material being tapped.

• It is important to use the correct drill size to ensure proper thread engagement.

• Using a drill size that is too small can result in weak threads, while using a drill size that is too large can damage the material.
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Q1. What is the role of IPQA.
Ans. 
IPQA stands for In-Process Quality Assurance. It involves monitoring and inspecting the quality of products during the manufacturing process.
• IPQA ensures that products meet quality standards at every stage of production

• It involves conducting inspections, tests, and audits to identify and address any quality issues

• IPQA helps in preventing defects and ensuring compliance with regulations and standards

• Examples include che...read more
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Q2. What is the ECR/BPR/BCR.
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ECR/BPR/BCR stands for Engineering Change Request/Business Process Reengineering/Business Case Reengineering.
• ECR (Engineering Change Request) is a formal proposal to make a change to a product's design or manufacturing process.

• BPR (Business Process Reengineering) is the analysis and redesign of workflows within and between enterprises to optimize end-to-end processes and eliminate non-value-added tasks.

• BCR (Business Ca...read more
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Q3. How to perform area clearance or equipment clearance.
Ans. 
Area or equipment clearance involves thorough cleaning and inspection to ensure safety and quality standards are met.
• Start by removing all items from the area or equipment being cleared.

• Clean the area or equipment using appropriate cleaning agents and tools.

• Inspect the area or equipment for any damage, wear and tear, or contamination.

• Document the clearance process and any findings for record-keeping purposes.

• Ensure pro...read more
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Q4. Review point of BPR/BCR/ECR
Ans. 
BPR/BCR/ECR are review points in business process management.
• BPR stands for Business Process Reengineering, involves radical redesign of processes for improvement.

• BCR stands for Business Continuity Review, ensures processes are in place to maintain operations during disruptions.

• ECR stands for Engineering Change Review, evaluates proposed changes to products or processes for impact.

• Review points help ensure efficiency,
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Q1. Salary discussion and company policies
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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. My work experience and related of the production output KPI
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