General Logic Interview Questions and Answers

To fix the specification limit for an unknown impurity in an API, conduct thorough analysis and consider regulatory guidelines.

• Perform comprehensive analysis of the impurity to determine its identity, properties, and potential risks

• Refer to regulatory guidelines and industry standards to establish acceptable limits for impurities

• Consider the impact of the impurity on the quality, safety, and efficacy of the API

• Collaborate with experts in analytical chemistry and toxicology to...read more

To prepare the QC laboratory for an audit, follow these steps:

• Ensure all equipment is calibrated and validated

• Review and update standard operating procedures (SOPs)

• Train laboratory personnel on audit procedures and expectations

• Perform internal audits to identify and address any non-compliance issues

• Organize and maintain documentation, including records of test results and equipment maintenance

• Implement a robust quality management system

• Conduct regular inspections and self-ass...read more

An OOS investigation is a process to determine the cause of an out-of-specification result in a product or process.

• OOS stands for Out-of-Specification.

• It involves a thorough investigation to identify the root cause of the deviation.

• The investigation may include reviewing manufacturing records, conducting laboratory tests, and analyzing data.

• One example of an OOS investigation is when a pharmaceutical product fails to meet its specified potency during quality control testing.

• T...read more

Validation is the process of checking if something meets certain criteria. Types of validation include data validation, form validation, and email validation.

• Validation is the process of ensuring that something meets specific requirements or standards.

• Data validation involves checking the accuracy, completeness, and consistency of data.

• Form validation ensures that user input in web forms is correct and meets specified criteria.

• Email validation verifies the format and existenc...read more

Incident management process involves identifying, responding to, and resolving incidents to minimize their impact on business operations.

• The process starts with incident identification, where incidents are reported or detected.

• Once an incident is identified, it is logged and categorized based on its severity and impact.

• A response team is then assigned to investigate and resolve the incident.

• During the investigation, the team gathers information, analyzes the root cause, and d...read more