10+ Senior Quality Assurance Officer Interview Questions and Answers

IPQC tests for tablets/capsules in manufacturing and packing include appearance, weight variation, disintegration, dissolution, and content uniformity.

• Appearance inspection for color, shape, and size

• Weight variation testing to ensure consistency

• Disintegration testing to check if the tablet/capsule breaks down properly

• Dissolution testing to assess the release of the active ingredient

• Content uniformity testing to verify uniform distribution of the active ingredient

CQA stands for Critical Quality Attributes and CPP stands for Critical Process Parameters for tablets and capsules.

• CQA are the key physical, chemical, biological, or microbiological characteristics that must be within an appropriate limit, range, or distribution to ensure the desired product quality.

• CPP are the key process parameters that should be controlled within a narrow range or set points to ensure the product meets the desired quality attributes.

• Examples of CQA for tab...read more

Process validation types include prospective, retrospective, and concurrent validation.

• Prospective validation involves establishing specifications and procedures before production.

• Retrospective validation involves reviewing historical data to verify processes were consistently in control.

• Concurrent validation involves monitoring and evaluating processes during production.

• Examples: Prospective validation - setting up new equipment. Retrospective validation - reviewing past pro...read more

Line clearance is the process of ensuring that a production line or area is free from any previous materials, tools, or equipment before starting a new process.

• Line clearance involves visually inspecting the production area to ensure it is clean and free of any leftover materials.

• It also involves verifying that all necessary tools and equipment are in place for the new process.

• Line clearance helps prevent contamination and mix-ups during production.

• Examples: cleaning a packag...read more

Change control is a process used to ensure that changes to a system are implemented in a controlled and systematic manner.

• Change control involves documenting and tracking changes to a system or process.

• It includes evaluating the impact of proposed changes and obtaining approval before implementation.

• Change control helps prevent unauthorized changes and ensures that all changes are properly tested and validated.

• Examples of change control include software updates, equipment upg...read more

Preventive maintenance is proactive maintenance performed on equipment or systems to prevent breakdowns and ensure optimal performance.

• Regularly scheduled inspections and servicing

• Replacing worn out parts before they fail

• Cleaning and lubricating machinery

• Updating software to prevent bugs or security vulnerabilities

In process samples are samples taken during the manufacturing process to monitor quality and ensure consistency.

• In process samples are collected at various stages of production to check for quality and consistency.

• These samples help identify any issues early on and prevent defects in the final product.

• They are typically tested for parameters such as purity, potency, and contamination.

• Examples include taking samples of a drug formulation during mixing or sampling a food produc...read more

Dispatch is the process of sending out goods or messages for delivery or transmission.

• Dispatch involves organizing and sending out items or information to their intended recipients.

• It is an important part of logistics and communication processes.

• Examples include dispatching packages for delivery, dispatching emergency services to a location, or dispatching messages to team members.

Sampling is the process of selecting a subset of individuals or items from a larger population to make inferences about the whole.

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

• Different sampling methods include random sampling, stratified sampling, and convenience sampling.

• Sampling helps in making predictions and generalizations about the population based on the sample.

• Sampling is commonly used in quality assurance to test a subset of products o...read more