Genesis Web Solutions Interview Questions and Answers

Qualification is the process of ensuring that equipment meets specified requirements, while calibration is the process of adjusting equipment to meet those requirements.

• Qualification ensures that equipment is suitable for its intended use, while calibration ensures that it is accurate and reliable.

• Qualification involves testing and verifying equipment performance, while calibration involves adjusting and verifying accuracy.

• Qualification is typically done before equipment is p...read more

Pharmacopial standards are official standards set by regulatory authorities, while non-pharmacopial standards are developed by organizations or manufacturers.

• Pharmacopial standards are legally enforceable, while non-pharmacopial standards are not.

• Pharmacopial standards ensure the quality, safety, and efficacy of pharmaceutical products.

• Non-pharmacopial standards may be specific to a particular organization or manufacturer.

• Examples of pharmacopial standards include the United ...read more

If potency is not maintained on pharmacopial standard, mention it as per the guidelines.

• If potency is not maintained on pharmacopial standard, it should be mentioned in the analytical report.

• The report should mention the actual potency value and the acceptable range as per the pharmacopial standard.

• The report should also mention the reason for the deviation from the standard and the corrective actions taken.

• The deviation should be reported to the regulatory authorities as per...read more

Pharmacopial changes can be performed by following the guidelines set by regulatory authorities and ensuring proper documentation.

• Review the regulatory guidelines for making pharmacopial changes

• Ensure that the changes are scientifically justified and do not compromise the quality, safety, and efficacy of the product

• Document the changes and obtain approval from the regulatory authorities before implementing them

• Communicate the changes to all relevant stakeholders, including ma...read more

Change control is a process of managing changes to a system or product. There are two types: preventive and corrective.

• Preventive change control is used to prevent potential problems by reviewing and approving changes before they are implemented.

• Corrective change control is used to correct problems that have already occurred by reviewing and approving changes to fix the problem.

• Change control involves documenting the change, assessing the impact of the change, obtaining appro...read more

Instrument qualification involves testing and verifying that an instrument meets its intended use and performance requirements.

• Develop a qualification plan that outlines the testing and acceptance criteria

• Perform installation qualification (IQ) to verify that the instrument is installed correctly

• Perform operational qualification (OQ) to verify that the instrument operates as intended

• Perform performance qualification (PQ) to verify that the instrument meets its performance req...read more