Medicamen Biotech QA Officer Interview Questions and Answers

Line clearance procedure is a process followed in pharmaceutical manufacturing to ensure that equipment and areas are free from any previous product or contamination before starting a new production.

• Line clearance procedure is performed to prevent cross-contamination and ensure product quality.

• It involves a series of checks and documentation to verify that the equipment, area, and materials are ready for use.

• Line clear...read more

ANF and Nutch filter are both used in the field of information retrieval, but they have different purposes and functionalities.

• ANF (Approximate Nearest Neighbor Filtering) is a technique used to efficiently filter out irrelevant data points in a dataset based on their proximity to a query point.

• Nutch filter, on the other hand, is a component of the Apache Nutch web crawler framework that is used to filter and prioritiz...read more

There are three types of line clearance: equipment line clearance, product line clearance, and area line clearance.

• Equipment line clearance involves ensuring that all equipment used in a production line is properly cleaned and free from any previous product or material.

• Product line clearance involves verifying that the previous product has been completely removed from the production line before starting a new product.

• A...read more

Difficulties during line clearance include time constraints, equipment availability, and potential contamination risks.

• Time constraints can make it challenging to thoroughly clean and inspect the production line before starting a new batch.

• Limited availability of cleaning equipment or resources can hinder the efficiency of line clearance.

• There is a risk of cross-contamination if residues or contaminants from the previo...read more

Observations can be classified as critical, major, or minor based on their impact on quality and compliance.

• Critical observations have a significant impact on product quality and regulatory compliance.

• Major observations have a moderate impact on product quality and regulatory compliance.

• Minor observations have a minimal impact on product quality and regulatory compliance.

• Observations can be related to equipment, proces...read more

CAPA flow involves identifying deviations, investigating root causes, implementing corrective actions, and verifying effectiveness.

• Identify the deviation or nonconformance

• Investigate the root cause using techniques like 5 Whys, Fishbone diagram

• Implement corrective actions to prevent recurrence

• Verify the effectiveness of the actions taken

• Document the entire CAPA process for future reference

HPLC stands for High Performance Liquid Chromatography, a technique used to separate, identify, and quantify components in a mixture.

• HPLC works on the principle of separating components in a mixture based on their interaction with a stationary phase and a mobile phase.

• The stationary phase is typically a column packed with a solid material, while the mobile phase is a liquid solvent that carries the sample through the c...read more

GLP stands for Good Laboratory Practice, a set of principles intended to ensure the quality and integrity of non-clinical laboratory studies.

• GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

• It ensures that the data generated in such studies are reliable and...read more