U S Pharmacopeia Associate Quality Assurance Team Lead Interview Questions, Process, and Tips

Stability study guidelines ensure the quality and shelf-life of products by testing their stability under various conditions.

• Stability studies should be conducted according to regulatory guidelines such as ICH guidelines.

• Samples should be stored at different temperatures and humidity levels to assess stability.

• Testing should be done at various time points to determine the shelf-life of the product.

• Data should be analyz...read more

Significant changes in stability testing require adherence to specific guidelines.

• Significant changes in stability testing must be documented and justified.

• Guidelines typically require notification to regulatory authorities for significant changes.

• Changes in stability testing conditions, such as temperature or humidity, may require revalidation.

• Any deviations from established stability protocols must be thoroughly inve...read more

Pro assessment for any changes involves thoroughly evaluating the impact of proposed changes before implementing them.

• Conducting risk assessments to identify potential issues

• Testing changes in a controlled environment

• Seeking feedback from stakeholders

• Analyzing data to measure the effectiveness of changes

Regularly back up all CDS and Non CDS applications software to ensure data integrity and availability.

• Schedule regular automated backups of all CDS and Non CDS applications software.

• Store backups in secure locations to prevent data loss in case of system failure.

• Test backup procedures regularly to ensure they are functioning correctly.

• Implement a disaster recovery plan to quickly restore applications in case of a major...read more

USFDA 483s are inspection observations issued by the FDA to a company detailing any violations found during inspections.

• USFDA 483s are issued to companies after inspections to notify them of any violations found during the inspection.

• Companies are required to respond to the 483s with a corrective action plan to address the violations.

• Failure to address the violations in a timely manner can lead to further regulatory ac...read more

Warning letters are issued by regulatory agencies to notify companies of violations and request corrective actions.

• Warning letters are issued by regulatory agencies such as the FDA, EPA, and FTC.

• They are sent to companies to address violations of regulations or laws.

• The letters outline the specific violations found during inspections or investigations.

• Companies are required to respond to warning letters with corrective...read more