Sample interview questions: How do you handle changes in process parameters or formulations during the manufacturing of pharmaceutical products?
Sample answer:
1. Establish a Robust Change Control Process:
– Implement a formal change control process that outlines steps for evaluating, approving, and implementing process parameter or formulation changes.
– Clearly define roles and responsibilities for individuals involved in the change control process, such as scientists, engineers, quality assurance personnel, and regulatory affairs specialists.
2. Conduct Thorough Risk Assessment:
– Evaluate the potential impact of changes on product quality, safety, and efficacy.
– Assess the potential impact on regulatory compliance, stability studies, and ongoing clinical trials.
– Utilize risk assessment tools such as Failure Modes and Effects Analysis (FMEA) to identify and prioritize potential risks.
3. Perform Rigorous Process Validation:
– Validate the revised process or formulation to ensure that it consistently meets predefined specifications and quality attributes.
– Conduct validation studies to demonstrate that the process is capable of producing products that meet all critical quality attributes.
– Ensure that validation studies are conducted in accordance with regulatory guidelines and Good Manufacturing Practices (GMP) requirements.
4. Maintain Comprehensive Documentation:
– Maintain detailed records of all changes made to process parameters or formulations, including rationale, supporting data, and risk assessments.
– Document all aspects of the change control process, including approvals, deviations, and corrective actions.
– Ensure that documentation is accurate, complete, and easily accessible to authorized personnel.
5. Communica… Read full answer
Source: https://hireabo.com/job/5_2_16/Pharmaceutical%20Chemist