Steril Gene Life Sciences QA Executive Interview Questions and Answers

The life cycle of change control involves planning, implementing, reviewing, and approving changes to a system or process.

• Planning: Identify the need for change and create a plan.

• Implementation: Make the necessary changes and document them.

• Review: Evaluate the effectiveness of the changes and identify any issues.

• Approval: Obtain approval from stakeholders before implementing the changes.

• Examples: Updating software, cha...read more

Artwork should be checked for accuracy and compliance with regulations.

• Verify all text is accurate and matches the approved copy

• Ensure all required elements are present and in the correct location

• Check for proper color usage and consistency

• Confirm compliance with regulatory requirements

• Perform a final proofread for any errors or inconsistencies

Guidelines for QMS, change control, stability, artwork etc.

• QMS guidelines should cover all aspects of quality management, including documentation, training, and audits.

• Change control guidelines should outline the process for making changes to products or processes, including documentation and approval requirements.

• Stability guidelines should cover the testing and monitoring of product stability over time, including sto...read more

pH is a measure of the acidity or alkalinity of a solution.

• pH stands for 'potential of hydrogen'.

• It is a logarithmic scale ranging from 0 to 14.

• A pH of 7 is considered neutral, below 7 is acidic, and above 7 is alkaline.

• pH is determined by the concentration of hydrogen ions in a solution.

• Examples: Lemon juice has a pH of around 2, while baking soda has a pH of around 9.

PH represents the concentration of hydrogen ions in a sample.

• PH is measured on a scale of 0-14, with 7 being neutral.

• A lower PH indicates higher acidity, while a higher PH indicates higher alkalinity.

• PH can be measured using a PH meter or through chemical indicators.

• The PH of a sample can affect its chemical properties and reactions.

LOD stands for Limit of Detection. It is the lowest concentration of a substance that can be reliably detected.

• LOD is used to determine the sensitivity of an analytical method.

• It is usually expressed as a concentration or mass.

• Water is a chemical compound composed of hydrogen and oxygen, while LOD is a term used in analytical chemistry.

• LOD is important in environmental testing to determine the presence of contaminants ...read more