Macleods Pharmaceuticals Senior Officer 2 Interview Questions and Answers

Validation in production involves ensuring that processes and products meet quality standards.

• Validation involves verifying that equipment, processes, and systems are operating correctly and consistently.

• Validation also includes confirming that products meet specifications and quality standards.

• Documentation of validation activities is essential for regulatory compliance and continuous improvement.

• Examples of validatio...read more

Safety permits are essential for ensuring compliance with regulations and maintaining a safe work environment.

• Safety permits are required for certain activities or equipment to ensure they meet safety standards.

• Production officers must be familiar with the types of safety permits needed in their industry.

• They are responsible for obtaining and renewing safety permits as needed.

• Failure to comply with safety permit requir...read more

Distillation is a process used to separate components of a liquid mixture based on differences in boiling points.

• Distillation involves heating the liquid mixture to create vapor, then cooling the vapor to condense it back into liquid form.

• The components with lower boiling points will vaporize first and be collected as the distillate, while the components with higher boiling points remain in the original container.

• Commo...read more

Deviations in production processes must be promptly identified, investigated, and documented to ensure product quality and compliance.

• Deviation should be reported immediately to the appropriate personnel

• Investigate the root cause of the deviation

• Document all findings and actions taken

• Implement corrective and preventive actions to prevent recurrence

• Review and approve deviation reports before closure

CAPA refers to Corrective and Preventive Actions taken to address non-conformities and prevent recurrence.

• Identify the root cause of the issue

• Develop a corrective action plan to address the issue

• Implement the corrective action plan

• Monitor the effectiveness of the corrective action

• Implement preventive actions to prevent recurrence

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

• Ensuring data is accurate and reliable

• Maintaining consistency of data

• Preventing unauthorized access or modifications

• Implementing data validation processes

• Regularly backing up data to prevent loss

Batch failures should be analyzed to identify root causes and prevent future occurrences.

• Investigate the root cause of the batch failure

• Implement corrective actions to prevent future failures

• Document the findings and actions taken for future reference

• Communicate with relevant stakeholders about the batch failure and resolution

• Conduct a review of the production process to identify potential areas for improvement

Handling of deviations involves identifying, investigating, and resolving any deviations from standard procedures or specifications.

• Deviation should be documented and reported immediately

• Investigate root cause of deviation

• Implement corrective and preventive actions

• Review and update procedures to prevent future deviations