Senior Executive QC Interview Questions and Answers

Handling NQI and QI incidents requires thorough evaluation and decision-making based on established protocols.

• Thoroughly investigate the incident to determine if it falls under NQI (Non-Quality Incident) or QI (Quality Incident).

• Refer to established guidelines, protocols, and quality standards to assess the severity and impact of the incident.

• Consider the potential risks to patient safety, regulatory compliance, and overall quality of the product or service.

• Consult with relev...read more

Extraneous peaks in GC analysis can be handled by identifying the source of contamination, adjusting parameters, and re-analyzing the sample.

• Identify the source of contamination by checking sample preparation, column condition, or instrument cleanliness.

• Adjust parameters such as temperature, flow rate, or injection volume to minimize extraneous peaks.

• Re-analyze the sample after making necessary adjustments to ensure accurate results.

• Consult with colleagues or experts if neede...read more

The formula for calculating CU value or AV is based on the number of defects found during quality control inspections.

• CU value (Criticality Unit) is calculated by assigning a weight to each type of defect based on its impact on the product or process.

• AV (Acceptance Value) is calculated by summing up the CU values of all defects found during inspections.

• Formula: AV = Σ(CU value of all defects)

• Example: If a product has 3 critical defects with CU values of 5, 7, and 10, the AV w...read more

Stability zones are environmental conditions for storing pharmaceutical products to ensure their stability and efficacy.

• Zone I: 25°C / 60% RH (e.g. refrigerated storage)

• Zone II: 30°C / 65% RH (e.g. controlled room temperature)

• Zone III: 30°C / 75% RH (e.g. accelerated storage)

• Zone IV: 40°C / 75% RH (e.g. stress testing)

UCL and LCL stand for Upper Control Limit and Lower Control Limit, respectively. They are statistical measures used in quality control to determine if a process is stable and in control.

• UCL is the highest value that a process can reach before it is considered out of control.

• LCL is the lowest value that a process can reach before it is considered out of control.

• UCL and LCL are typically calculated using statistical methods such as control charts and formulas based on process d...read more

Dissolution criteria for extended release drugs are set to ensure the drug releases over a specific time period.

• Dissolution criteria are typically based on the release profile of the drug over time.

• Criteria may include the percentage of drug released at specific time points.

• For example, a common criteria for extended release drugs is that at least 80% of the drug should be released in 8 hours.

• The criteria are important for ensuring the drug's effectiveness and safety.

Method validation for Assay by HPLC involves testing the accuracy, precision, specificity, and linearity of the method.

• The method should be tested for accuracy by comparing the results obtained with a reference standard or method.

• Precision can be determined by analyzing multiple samples and calculating the standard deviation.

• Specificity can be tested by analyzing samples with known interferences and ensuring they do not interfere with the assay.

• Linearity can be determined by ...read more

Audit trails are logs that track changes made to data, providing a record of who made the changes, when, and why.

• Audit trails are essential for maintaining data integrity and compliance with regulations.

• They help in identifying errors, fraud, or unauthorized access to data.

• Examples of audit trails include logs of user actions in a software system, changes made to a document, or modifications to a database.

• Audit trails should be secure, tamper-evident, and easily accessible fo...read more