Senior Officer QA
Senior Officer QA Interview Questions and Answers
Q1. What is line clearance at different stages
Line clearance at different stages refers to the process of ensuring that a production line or area is free from any previous product or material before starting a new production or process.
Line clearance is performed at various stages such as before starting a new batch, after completing a batch, or during equipment changeover.
It involves thorough cleaning, removal of any residual material, and verification of cleanliness.
Line clearance is important to prevent cross-contamin...read more
Q2. What is AQL sampling and limits
AQL sampling is a statistical method used in quality control to determine the acceptable quality level of a product batch.
AQL stands for Acceptable Quality Level, which is the maximum percentage of defective units that is considered acceptable in a batch of products.
AQL sampling involves randomly selecting a sample of units from a batch and inspecting them for defects.
The AQL limits are predetermined values that specify the maximum number of defective units allowed in a sampl...read more
Q3. How does a microwave oven works.
Microwave ovens use electromagnetic radiation to heat food by exciting water molecules within it.
Microwaves are a form of electromagnetic radiation with a wavelength ranging from 1 millimeter to 1 meter.
The microwaves penetrate the food and cause the water molecules to vibrate, generating heat through friction.
The rotating plate inside the microwave helps to ensure even heating of the food.
Metal objects should not be placed inside a microwave as they can cause sparks due to r...read more
Q4. How to perform sampling?
Sampling is the process of selecting a subset of a population to represent the entire group for testing or analysis.
Determine the population to be sampled
Choose a sampling method (random, stratified, cluster, etc.)
Decide on the sample size
Collect the samples
Analyze the samples and draw conclusions
Q5. What is mediafill interventions
Mediafill interventions are activities conducted to assess the effectiveness of aseptic processes in pharmaceutical manufacturing.
Mediafill interventions involve simulating the manufacturing process using a sterile growth medium instead of the actual product.
These interventions are performed to evaluate the capability of personnel, equipment, and facilities to maintain sterility during production.
During mediafill interventions, samples are collected and tested for microbial c...read more
Q6. What Are Class A preserative.
Class A preservatives are antimicrobial agents that are considered safe for use in food and pharmaceutical products.
Class A preservatives are substances that prevent the growth of microorganisms in products.
They are considered safe for consumption and are approved by regulatory authorities.
Examples of Class A preservatives include sodium benzoate, potassium sorbate, and parabens.
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Q7. What is deviation?
Deviation is a departure from a standard or norm, often in the context of quality assurance.
Deviation is a variation from an established process or procedure.
It can be caused by human error, equipment malfunction, or external factors.
Deviation must be documented, investigated, and corrective actions taken to prevent recurrence.
Examples include a machine malfunction causing a product defect or a missed step in a manufacturing process.
Q8. What is media fill
Media fill is a simulation test used in pharmaceutical manufacturing to ensure the aseptic filling process is performed correctly.
Media fill involves filling sterile growth media instead of actual product to simulate the manufacturing process.
The filled containers are then monitored for any microbial growth to ensure the process is aseptic.
Media fill tests are conducted periodically to validate the aseptic filling process and equipment.
Examples of media fill tests include fil...read more
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