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RAMBARAN SINGH APEX Interview Questions and Answers

Updated 5 Feb 2024
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Q1. What is Good manufacturing practices

Ans.

Good manufacturing practices (GMP) are guidelines that ensure products are consistently produced and controlled according to quality standards.

  • GMP are regulations that cover all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff.

  • They are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

  • Examples of GMP include proper documen...read more

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Q2. How to good laboratory practice

Ans.

Good laboratory practice involves following standardized procedures, maintaining cleanliness, and ensuring accuracy in testing.

  • Follow standardized procedures for all tests and experiments

  • Maintain cleanliness and organization in the laboratory

  • Ensure accuracy in testing by double-checking results and calibrating equipment regularly

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Q3. What is quality assurance

Ans.

Quality assurance is the process of ensuring that products or services meet specified requirements and standards.

  • Quality assurance involves creating processes and procedures to prevent defects in products or services.

  • It focuses on continuous improvement and monitoring to ensure consistent quality.

  • Quality assurance often includes testing, inspections, and audits to identify and correct issues.

  • Examples of quality assurance activities include software testing, product inspection...read more

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Q4. How to validation process

Ans.

Validation process ensures that the software meets the specified requirements and functions correctly.

  • Validation process involves testing the software against the requirements to ensure it functions as expected.

  • It includes functional testing, usability testing, performance testing, and security testing.

  • Validation process also involves user acceptance testing to ensure the software meets the user's needs.

  • Validation process is essential to ensure the quality and reliability of ...read more

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Q5. Explain sop procedure

Ans.

Standard Operating Procedure (SOP) is a detailed step-by-step guide on how to perform a specific task or process.

  • SOP procedures outline the necessary steps, tools, and resources required to complete a task.

  • They ensure consistency, quality, and compliance with regulations.

  • SOPs are commonly used in industries such as healthcare, manufacturing, and software development.

  • Examples of SOP procedures include how to conduct software testing, how to clean medical equipment, and how to ...read more

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Q6. Explain iq,PQ,DQ,oq

Ans.

IQ, PQ, DQ, OQ are validation protocols used in the pharmaceutical industry to ensure equipment and processes meet regulatory requirements.

  • IQ stands for Installation Qualification, which verifies that equipment is installed correctly and according to specifications.

  • PQ stands for Performance Qualification, which ensures that equipment consistently performs as intended in a specific environment.

  • DQ stands for Design Qualification, which confirms that the design of the equipment ...read more

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