Macleods Pharmaceuticals QA Officer Interview Questions and Answers

Validation sampling is a process of selecting a subset of data from a larger population to assess the accuracy and reliability of a validation method.

• Validation sampling is used to evaluate the performance of a validation process or method.

• It involves selecting a representative sample from a larger population.

• The sample should be chosen randomly to ensure unbiased results.

• The size of the sample should be sufficient to ...read more

The challenge in primary and secondary process is to ensure quality and consistency of the product.

• Ensuring proper documentation and record keeping

• Maintaining equipment and facilities

• Training and monitoring personnel

• Performing regular quality checks and audits

• Addressing any deviations or non-conformances

• Ensuring compliance with regulatory requirements

• Maintaining product integrity throughout the supply chain

NFD CAMERA faces challenges in detecting and identifying non-fluorescent dyes.

• NFD CAMERA struggles to detect non-fluorescent dyes due to their lack of fluorescence.

• This can lead to false negatives in identifying certain substances.

• Alternative methods, such as colorimetric assays, may need to be used in conjunction with NFD CAMERA.

• NFD CAMERA may also struggle with samples that have high levels of autofluorescence.

• Regula...read more

Fragility test is done to determine the ability of a product to withstand mechanical shocks during transportation or handling.

• To ensure the product's safety during transportation or handling

• To identify potential weaknesses or defects in the product

• To comply with regulatory requirements

• To prevent damage or loss of the product

• Examples include drop test, vibration test, and compression test

The indicator used in leak test depends on the type of test being performed.

• For pressure decay test, pressure gauges are used as indicators.

• For bubble emission test, a solution of soap and water is used as an indicator.

• For vacuum decay test, a vacuum gauge is used as an indicator.

• Helium mass spectrometry is used as an indicator for helium leak test.

• The choice of indicator depends on the sensitivity and accuracy require...read more