SMS Pharmaceuticals Quality Control Reviewer Interview Questions and Answers

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data is accurate if it is free from errors and reflects the true state of the information it represents.

• Data is consistent if it is uniform and follows a set of predefined rules or standards.

• Data is reliable if it can be trusted to be available and accessible when needed.

• Examples of maintaining data integrity include re...read more

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data integrity ensures that data remains unchanged and reliable over time.

• It involves maintaining the accuracy and consistency of data during storage, processing, and transmission.

• Data integrity can be achieved through various measures such as checksums, encryption, and access controls.

• Examples of data integrity issues ...read more

CAPA stands for Corrective and Preventive Action.

• CAPA is a systematic approach to identify, investigate, and resolve quality issues.

• It involves analyzing the root cause of the problem and implementing corrective actions to prevent recurrence.

• CAPA is commonly used in industries such as manufacturing, pharmaceuticals, and healthcare.

• Examples of CAPA tools and techniques include 5 Whys, Fishbone Diagrams, and Pareto Analy

Calibration is required to ensure accuracy and consistency of measurements and equipment.

• Calibration helps to maintain the quality of products and services.

• It ensures that measurements are accurate and consistent, reducing errors and improving efficiency.

• Calibration is necessary for compliance with industry standards and regulations.

• Examples of equipment that require calibration include scales, thermometers, and medica...read more

I would clarify the reason behind the request and discuss any potential impact on the analysis.

• Ask for clarification on the reason for skipping the step

• Discuss any potential impact on the analysis

• Provide alternative solutions if possible

Aseptic process is a method of sterilization used to prevent contamination in sterile environments. Media and Media Fill Validation are used to ensure the sterility of the media used in the process. Autoclave daily and non-routine cycles are methods of sterilization used in the process.

• Aseptic process is used to prevent contamination in sterile environments

• Media and Media Fill Validation are used to ensure the sterilit...read more