10 Basic Questions asked during IPQA Interview

1. What is IPQA, and what is its importance in the pharmaceutical industry?

Answer: IPQA stands for In-Process Quality Assurance, and it involves ensuring that the production process is in compliance with the regulatory requirements and follows the Standard Operating Procedures (SOPs). The importance of IPQA lies in ensuring that the final product meets the required quality standards and is safe for human use.

2. What are the key responsibilities of an IPQA professional?

Answer: The key responsibilities of an IPQA professional include conducting in-process testing, reviewing batch records, investigating deviations, ensuring compliance with regulatory requirements and SOPs, and participating in the qualification and validation process.

3. What is your experience with conducting in-process testing during pharmaceutical production?

Answer: I have experience conducting in-process testing, which involves checking various parameters such as pH, temperature, and viscosity at different stages of the manufacturing process. This ensures that the production process is on track and that the final product meets the required quality standards.

4. Can you explain the difference between in-process testing and finished product testing?

Answer: In-process testing involves checking various parameters during the manufacturing process to ensure that the process is on track, while finished product testing involves checking the final product to ensure that it meets the required quality standards before it is released for distribution.

5. How do you ensure that the manufacturing process follows the Standard Operating Procedures (SOPs) and regulatory requirements?

Answer: I ensure that the manufacturing process follows the SOPs and regulatory requirements by conducting regular audits and inspections, reviewing documentation, and providing training to personnel. I also collaborate with other departments to ensure that any changes to the process or procedures are properly reviewed and approved before implementation.

6. How do you handle deviations during the manufacturing process, and what is the procedure for investigating them?

Answer: When a deviation occurs, I document it and investigate its root cause. I work with other departments to determine the appropriate corrective and preventive actions to take. The investigation process involves gathering and analyzing data, reviewing documentation, and interviewing personnel to determine the root cause.

7. Can you explain the qualification and validation process in the pharmaceutical industry, and how does IPQA contribute to it?

Answer: The qualification and validation process involves ensuring that the manufacturing process, equipment, and facilities meet the required standards and are capable of producing quality products. IPQA contributes to this process by conducting in-process testing, reviewing documentation, and participating in the investigation of deviations.

8. What are the critical quality attributes (CQAs) in pharmaceutical manufacturing, and how do you ensure they are met during the production process?

Answer: Critical quality attributes are the characteristics of a product that are critical to ensuring its safety, efficacy, and quality. Examples include purity, potency, and stability. We ensure that these attributes are met during the production process by conducting in-process testing, reviewing documentation, and participating in the investigation of deviations.

9. Can you describe the role of IPQA in the review and approval of batch records and other production documents?

Answer: IPQA plays a critical role in the review and approval of batch records and other production documents. We review these documents to ensure that they are complete, accurate, and in compliance with regulatory requirements and SOPs. We also approve these documents before the product is released for distribution.

10. What are some common challenges that arise during IPQA, and how do you handle them?

Answer: Some common challenges that arise during IPQA include deviations from the process or procedures, equipment failures, and changes in the production environment. To handle these challenges, we document and investigate any deviations, work with other departments to determine the appropriate corrective and preventive actions, and provide training to personnel as necessary. We also collaborate with other departments to ensure that any changes to the process or procedures are properly reviewed and approved before implementation.