10+ Senior Officer QA Interview Questions and Answers

Changing dissolution limits affects drug release, bioavailability, and regulatory compliance.

• Dissolution limits determine how quickly a drug releases its active ingredient in the body.

• A tighter limit may enhance bioavailability, leading to improved therapeutic effects.

• For example, if a tablet's dissolution limit is changed from 30 minutes to 15 minutes, it may lead to faster onset of action.

• Conversely, a looser limit could result in slower drug release, potentially reducing e...read more

The sampling process during compression ensures quality control by selecting representative samples for testing.

• Identify critical quality attributes (CQAs) to monitor during compression.

• Select a statistically valid sample size based on batch size.

• Use random sampling techniques to avoid bias, e.g., selecting every 10th tablet.

• Conduct tests on samples for uniformity, potency, and dissolution rates.

• Document findings and adjust the compression process if deviations are found.

Validation ensures that a product meets specified requirements and functions correctly in its intended environment.

• Define validation criteria based on user needs and regulatory requirements.

• Conduct validation planning, including scope, resources, and timelines.

• Execute validation activities such as testing, inspections, and reviews.

• Document results and ensure traceability to requirements.

• Examples include software validation in medical devices or pharmaceuticals.

The sampling process involves defining the population, selecting a sample, and analyzing data to draw conclusions.

• Define the population: Identify the entire group you want to study, e.g., all patients in a hospital.

• Determine the sample size: Decide how many individuals to include in the sample, e.g., 100 patients.

• Select the sampling method: Choose a technique like random sampling or stratified sampling, e.g., random selection of patients.

• Collect the data: Gather information f...read more

Calibrating friability involves assessing tablet durability through controlled mechanical stress tests.

• 1. Prepare a sample of tablets to be tested for friability.

• 2. Use a friabilator, which is a device designed to subject tablets to mechanical stress.

• 3. Set the friabilator to a specific speed and time, typically 100 revolutions for 4 minutes.

• 4. Weigh the tablets before and after the test to determine weight loss.

• 5. Calculate the percentage of weight loss to assess friability;...read more

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

Deviation refers to a departure from established standards or protocols in processes or results.

• Deviation indicates a non-conformance to predefined specifications.

• It can occur in manufacturing, clinical trials, or quality control processes.

• Example: A batch of medication fails to meet potency specifications.

• Deviations must be documented and investigated to determine root causes.

• They can be classified as minor or major based on their impact on quality.

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

Composite sampling involves collecting multiple samples from different locations to create a representative sample.

• Identify the sampling area and divide it into sub-locations.

• Collect samples from each sub-location using consistent methods.

• Combine the individual samples into one composite sample.

• Ensure proper labeling and documentation of each sample.

• Example: In soil testing, collect samples from various depths and locations to analyze overall soil quality.

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

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.

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.

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

The process of making syrup and suspension involves mixing active ingredients with a liquid base to create a homogeneous mixture.

• Start by measuring out the active ingredients and the liquid base.

• Mix the active ingredients with the liquid base thoroughly to ensure uniform distribution.

• Use appropriate equipment such as a mixer or homogenizer to achieve a smooth consistency.

• Consider factors like pH, viscosity, and stability when formulating the syrup or suspension.

• Perform qualit...read more