Sr. Officer Ipqa Interview Questions and Answers

The limit of pressure differential in manufacturing area and packing section should be maintained within specified ranges to ensure product quality and safety.

• Pressure differentials are typically monitored to prevent contamination and ensure proper airflow in cleanrooms and controlled environments

• In manufacturing areas, the pressure differential should be maintained to prevent cross-contamination between different production areas

• In the packing section, pressure differentials...read more

Critical parameters during manufacturing area are key factors that directly impact the quality and safety of the products being produced.

• Temperature control

• Humidity levels

• Pressure levels

• Cleanliness and sanitation

• Equipment calibration and maintenance

• Raw material quality

• Process time and speed

• Employee training and adherence to SOPs

Documents issuance procedure involves requesting, reviewing, approving, and distributing documents as per SOPs.

• Request for document issuance is made by the concerned department or individual.

• Documents are reviewed by the Quality Assurance team to ensure compliance with SOPs.

• Approved documents are then distributed to relevant stakeholders.

• A log or record is maintained for tracking document issuance and distribution.

• Any revisions or updates to documents are also documented and ...read more

Validation and qualification are essential processes in ensuring the quality and reliability of products and processes in pharmaceutical manufacturing.

• Validation is the process of establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

• Qualification is the process of demonstrating that equipment, systems, and processes are suitable for ...read more