Associate Quality Assurance Team Lead

Associate Quality Assurance Team Lead Interview Questions and Answers

Updated 20 Aug 2023

Q1. What's difference between USFDA and MHRA OOS Investigation?

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USFDA and MHRA OOS investigations differ in terms of regulatory guidelines and procedures.

USFDA follows regulations set by the Food and Drug Administration in the United States, while MHRA follows guidelines set by the Medicines and Healthcare products Regulatory Agency in the UK.
USFDA focuses on ensuring the safety and efficacy of food and drugs in the US market, while MHRA focuses on the same in the UK market.
USFDA may have specific requirements for OOS investigations outli...read more

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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 action by the FDA.
Examples of common violations found in 483...read more

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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 outage.
Document backup procedures and train team members ...read more

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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 actions and plans to prevent future violations.
Failure to...read more

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Ans.

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 investigated.
Changes in stability testing may impact product s...read more

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

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USP Current version is a reference book that provides standards for pharmaceuticals, dietary supplements, and healthcare products.

USP stands for United States Pharmacopeia
Current version is USP 44-NF 39, released in November 2021
It includes standards for drug substances, dosage forms, excipients, and dietary supplements

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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 analyzed to identify any degradation or changes in the product o...read more