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Fresenius Kabi Team Leader-Quality Assurance/Quality Control Interview Questions and Answers

Updated 5 Feb 2024

Q1. Tell me sampling process in raw material

Ans.

Sampling process in raw material involves selecting a representative portion of the material for testing.

  • Identify the lot or batch number of the raw material

  • Select a random sample from the lot or batch

  • Ensure the sample is representative of the entire lot or batch

  • Test the sample for quality and purity

  • Accept or reject the lot or batch based on the test results

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Q2. What is pH calibration point

Ans.

pH calibration point is the value at which a pH meter is calibrated to ensure accurate readings.

  • pH calibration point is a reference point used to calibrate pH meters.

  • It is usually set to pH 7.0, which is considered neutral.

  • Other calibration points may be used depending on the specific application.

  • Calibration is important to ensure accurate pH measurements.

  • Calibration should be performed regularly to maintain accuracy.

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Ans.

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

  • It ensures that data is reliable and trustworthy.

  • It involves maintaining the accuracy and consistency of data over time.

  • It includes measures to prevent unauthorized access, modification, or deletion of data.

  • Examples of data integrity measures include data backups, access controls, and audit trails.

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Ans.

ALCOVA stands for Analysis of Covariance

  • ALCOVA is a statistical method used to analyze the relationship between a dependent variable and one or more independent variables while controlling for the effects of other variables.

  • It is commonly used in experimental research to determine if there is a significant difference between groups after controlling for a covariate.

  • ALCOVA is similar to ANCOVA (Analysis of Covariance) but includes additional variables in the analysis.

  • Example: ...read more

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Ans.

UV principal refers to the use of ultraviolet light to detect and analyze substances.

  • UV principal involves the use of ultraviolet light to identify and quantify substances.

  • It is commonly used in forensic science to detect bodily fluids and other trace evidence.

  • UV principal is also used in chemistry to analyze the composition of materials.

  • It works by measuring the absorption or emission of UV light by a substance.

  • UV principal can be used in combination with other analytical te...read more

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Ans.

UV is used for various purposes such as sterilization, curing, and detection.

  • UV light is used for sterilization of surfaces, water, and air.

  • UV curing is used in industries such as printing, electronics, and automotive for drying and hardening materials.

  • UV detection is used in forensic science to detect bodily fluids and in medical fields for diagnosis and treatment.

  • UV light is also used in tanning beds for artificial tanning.

  • Exposure to UV light can cause skin damage and incr...read more

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Ans.

OOS stands for Out of Specification.

  • OOS refers to a result that falls outside the specifications or acceptance criteria.

  • It is a deviation from the expected or desired result.

  • OOS can occur due to various reasons such as equipment malfunction, human error, or sample contamination.

  • In quality control, OOS results are investigated to determine the root cause and prevent future occurrences.

  • Examples of OOS in pharmaceutical industry include failed drug potency tests or impurity leve...read more

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