RMSI Interview Questions and Answers

Parameters in an analytical method validation include accuracy, precision, specificity, linearity, range, and robustness.

• Accuracy: the closeness of test results to the true value

• Precision: the closeness of agreement between individual test results

• Specificity: the ability to assess the analyte in the presence of other components

• Linearity: the ability to obtain test results that are directly proportional to the analyte concentration

• Range: the interval between the upper and lowe...read more

Forced degradation studies are conducted to determine the stability and degradation pathways of a drug or product.

• Forced degradation studies are performed to simulate the degradation of a drug or product under extreme conditions.

• The purpose is to understand the degradation pathways, identify potential impurities, and evaluate the stability of the drug or product.

• These studies help in establishing appropriate storage conditions, shelf life, and formulation strategies.

• Forced de...read more

There are several types of validations used in manufacturing processes.

• Process validation: ensuring that a manufacturing process consistently produces a product that meets predetermined quality standards.

• Equipment validation: verifying that manufacturing equipment is properly calibrated and functioning correctly.

• Cleaning validation: confirming that cleaning procedures effectively remove residues and contaminants from equipment.

• Analytical method validation: validating the accu...read more

Further action should be taken to prevent or mitigate degradation in manufacturing processes.

• Identify the root cause of degradation

• Implement corrective actions to address the root cause

• Monitor and measure the effectiveness of the corrective actions

• Continuously improve processes to prevent future degradation

• Train and educate employees on best practices and quality standards

• Implement preventive maintenance programs

• Regularly inspect and maintain equipment

• Ensure proper storage an...read more

Activities in QMS include establishing quality objectives, conducting audits, managing nonconformities, and continuous improvement.

• Establishing quality objectives to ensure products meet customer requirements

• Conducting audits to assess compliance with quality standards

• Managing nonconformities by identifying and addressing deviations from quality requirements

• Implementing corrective and preventive actions to prevent recurrence of issues

• Monitoring and measuring processes to ensu...read more