FDC Senior Officer Interview Questions and Answers

Calibration of instruments is essential for accurate measurements and reliable results.

• Calibration ensures that instruments are accurate and reliable

• It involves comparing measurements taken by the instrument to a known standard

• Adjustments are made to the instrument to bring it into alignment with the standard

• Calibration should be performed regularly to maintain accuracy

• Examples of instruments that require calibration i...read more

Guidelines for stability study

• Stability studies are conducted to determine the shelf life of a product

• The study should include testing of physical, chemical, and microbiological properties

• The study should be conducted at different temperatures and humidity levels

• The study should be conducted on different batches of the product

• The study should be conducted for a duration that is representative of the intended shelf life

• ...read more

OOS in dissolution test refers to an out-of-specification result in the dissolution test.

• OOS can occur due to various reasons such as improper sample preparation, incorrect testing conditions, or instrument malfunction.

• It is important to investigate the root cause of OOS and take corrective actions to prevent it from happening in the future.

• Examples of corrective actions include retesting the sample, adjusting testing ...read more

pH meter is calibrated with five standards to ensure accuracy and reliability of the readings.

• Calibration with multiple standards helps to detect any errors or inconsistencies in the readings.

• Different standards cover a range of pH values, allowing for a more comprehensive calibration.

• Using multiple standards also helps to account for any changes in the electrode over time.

• The five standard solution usually includes pH...read more

Detectors are used in HPLC to detect and quantify the separated components of a sample.

• Detectors measure the amount of analyte passing through the column.

• Common types of detectors include UV-Vis, fluorescence, and mass spectrometry.

• UV-Vis detectors measure absorbance of light by the analyte.

• Fluorescence detectors measure the emission of light by the analyte.

• Mass spectrometry detectors measure the mass-to-charge ratio o...read more

Calibration of spectrophotometer is a process of adjusting the instrument to ensure accurate and precise measurements.

• Calibration involves comparing the readings of the spectrophotometer to a known standard

• Adjustments are made to the instrument to ensure it is reading accurately

• Calibration should be performed regularly to maintain accuracy

• Examples of standards used for calibration include NIST traceable standards and c...read more