Qams Interview Questions and Answers

Batch coding is the process of assigning a unique code to a specific batch of a product. Process validation is the process of ensuring that a manufacturing process consistently produces a product that meets predetermined quality standards.

• Batch coding helps in tracking and tracing the product in case of any quality issues or recalls

• Process validation involves testing and verifying the manufacturing process to ensure that it consistently produces a product that meets the desir...read more

Mining of parenterals refers to the process of extracting and purifying drugs or nutrients from parenteral solutions.

• Parenterals are sterile solutions that are administered through injection or infusion.

• Mining involves separating the active ingredients from the solution and purifying them.

• This process is important for ensuring the safety and efficacy of parenteral drugs and nutrients.

• Examples of parenteral drugs include insulin, antibiotics, and chemotherapy drugs.

• Parenteral ...read more

21 CFR is a set of regulations issued by the FDA that governs food, drugs, medical devices, and cosmetics in the United States.

• 21 CFR stands for Title 21 of the Code of Federal Regulations

• It covers regulations related to food and drugs, medical devices, cosmetics, and more

• It is enforced by the FDA to ensure safety and efficacy of products

• Data entry refers to the process of inputting data into a system or database

• Accurate data entry is crucial in the medical field to ensure pa...read more

CAPA is important to identify and correct problems in processes, products, and services.

• Helps to prevent recurrence of issues

• Improves quality and reliability of products/services

• Ensures compliance with regulations and standards

• Enhances customer satisfaction

• Examples: Corrective action taken to fix a defect in a medical device, preventive action taken to avoid a safety hazard in a manufacturing process