100+ Quality Control Officer Interview Questions and Answers

Pharmacy is the science and technique of preparing, dispensing, and reviewing drugs and providing additional clinical services.

• Pharmacy involves the preparation and dispensing of drugs

• Pharmaceutical companies use various types of chemicals such as active pharmaceutical ingredients (APIs), excipients, and solvents

• APIs are the main active ingredients in a drug that provide the therapeutic effect

• Excipients are inactive substances that help deliver the drug to the body

• Solvents ar...read more

pH is a measure of acidity or alkalinity. Quality control ensures products meet standards. Quality assurance ensures processes meet standards.

• pH is a measure of the concentration of hydrogen ions in a solution, indicating its acidity or alkalinity

• Quality control involves inspecting and testing products to ensure they meet predetermined standards

• Quality assurance focuses on ensuring that processes and procedures are in place to consistently produce products that meet quality s...read more

The stationary phase used in HPLC can be either polar or non-polar.

• Polar stationary phases are used for separating polar compounds, while non-polar stationary phases are used for separating non-polar compounds.

• Common polar stationary phases include silica gel and alumina, while common non-polar stationary phases include C18 and C8.

• The choice of stationary phase depends on the properties of the sample being analyzed and the desired separation.

• The stationary phase is typically ...read more

Therapeutic effect refers to the positive impact of a medical treatment on a patient's health. GDP stands for Good Distribution Practice.

• Therapeutic effect is the desired outcome of a medical treatment

• It can be measured by improvements in symptoms or overall health

• For example, the therapeutic effect of an antibiotic is the elimination of an infection

• GDP is a set of guidelines for ensuring the quality and safety of pharmaceutical products during distribution

• It includes require...read more

Assay is a test to determine the potency or purity of a drug or substance.

• Assay is done to ensure that the drug or substance meets the required standards.

• It helps in determining the concentration of the active ingredient in a drug.

• Assay can also be used to detect impurities or contaminants in a drug.

• It is an important part of quality control in the pharmaceutical industry.

• Examples of assays include HPLC, GC, and spectrophotometry.

Semipermeable membrane is a type of membrane that allows certain molecules to pass through while blocking others.

• It is a thin layer of material that selectively allows certain molecules to pass through

• Examples include cell membranes and dialysis tubing

• The membrane is made up of tiny pores or channels that allow small molecules to pass through

• It is used in various applications such as water filtration and drug delivery systems

High and low permeability membranes are used in filtration processes to control the flow of substances.

• High permeability membranes allow for a greater flow of substances through the membrane.

• Low permeability membranes restrict the flow of substances through the membrane.

• Permeability is determined by the size of the pores in the membrane.

• Examples of high permeability membranes include ultrafiltration membranes used in water treatment.

• Examples of low permeability membranes incl...read more

To manufacture 10 lakh tablets of paracetamol 500 mg API, you would need a certain amount of grams or kilograms of API.

• To find the amount of API needed, we need to calculate the total quantity required for 10 lakh tablets.

• First, convert 10 lakh tablets to the number of milligrams (mg) by multiplying by 500 mg (the dosage of each tablet).

• Then, convert the total milligrams to grams or kilograms by dividing by 1000.

• The resulting value will be the amount of API needed to manufact...read more

A swab sample involves using a swab to collect a sample from a specific area, while a rinse sample involves rinsing a larger area to collect a sample.

• Swab sample: Collects a sample from a specific area using a swab.

• Rinse sample: Involves rinsing a larger area to collect a sample.

• Swab samples are commonly used for surface testing, such as swabbing a countertop or equipment.

• Rinse samples are often used for environmental testing, such as rinsing a large area of a production floo...read more

I have handled various instruments including calipers, micrometers, gauges, and spectrophotometers.

• Calipers for measuring distance between two opposite sides of an object

• Micrometers for measuring small distances with high precision

• Gauges for measuring various parameters such as pressure, temperature, and humidity

• Spectrophotometers for measuring the intensity of light in a spectrum

• Also familiar with pH meters, balances, and pipettes

• Regularly trained on new instruments and thei...read more

Acidic substances have a pH less than 7, while basic substances have a pH greater than 7.

• Acids release hydrogen ions (H+) when dissolved in water.

• Bases release hydroxide ions (OH-) when dissolved in water.

• Examples of acids include vinegar, lemon juice, and battery acid.

• Examples of bases include baking soda, bleach, and ammonia.

Osmosis is the movement of solvent molecules from a region of low solute concentration to a region of high solute concentration through a semi-permeable membrane. Osmotic pressure is the pressure required to prevent the movement of solvent molecules through the membrane.

• Osmosis is a type of passive transport.

• It occurs in living cells and is important for maintaining cell shape and function.

• Osmotic pressure is influenced by the concentration of solutes on either side of the me...read more

Physical compatibility refers to the ability of two substances to be mixed or combined without any physical changes. Chemical compatibility refers to the ability of two substances to be mixed or combined without any chemical reactions.

• Physical compatibility is about the physical properties of substances, such as solubility, viscosity, and stability.

• Chemical compatibility is about the chemical properties of substances, such as reactivity, acidity, and compatibility with other ...read more

The color seen in the test solution depends on the type of test being conducted.

• The color change indicates the presence or absence of a particular substance in the solution.

• Different tests use different indicators to produce a color change.

• For example, a pH test may use litmus paper to indicate acidity or alkalinity.

• A glucose test may use a reagent that changes color in the presence of glucose.

• The color seen in the test solution can be compared to a color chart to determine t...read more

Distillation is a process of separating components of a mixture based on their boiling points. Dilution is the process of reducing the concentration of a solution by adding more solvent.

• Distillation involves heating a mixture to vaporize the component with the lowest boiling point, then condensing the vapor to collect the purified component.

• Dilution is commonly used in chemistry to prepare solutions of a desired concentration.

• Distillation and dilution are both important techn...read more

The chemical composition of iron ore varies depending on the type of ore and its source.

• Iron ore is primarily composed of iron oxides, such as hematite and magnetite.

• Other elements present in iron ore include silica, alumina, phosphorus, sulfur, and trace amounts of various metals.

• The specific chemical composition of iron ore can vary widely, even within the same deposit or mine.

• For example, a typical chemical composition of iron ore may include around 60-70% iron, 2-6% silic...read more

There are numerous compatibilities in pharmaceutical industry depending on the type of drug, dosage form, and excipients used.

• Drug-excipient compatibility

• Drug-dosage form compatibility

• Excipient-excipient compatibility

• Container-drug compatibility

• Drug-stability compatibility

HPLC stands for High Performance Liquid Chromatography. It is a technique used to separate, identify, and quantify components in a mixture.

• HPLC works on the principle of separation of components based on their interaction with the stationary phase and mobile phase.

• The stationary phase is a solid or liquid material that is packed into a column, while the mobile phase is a liquid that flows through the column.

• The sample is injected into the mobile phase and as it flows through ...read more

Qualitative analysis is subjective and deals with non-numerical data while quantitative analysis is objective and deals with numerical data.

• Qualitative analysis deals with non-numerical data while quantitative analysis deals with numerical data.

• Qualitative analysis is subjective while quantitative analysis is objective.

• Qualitative analysis is used to gain insights and understanding while quantitative analysis is used to measure and quantify.

• Examples of qualitative analysis in...read more

The quality control department ensures that pharmaceutical products meet the required standards and regulations.

• Ensuring compliance with regulatory requirements

• Testing and analyzing raw materials, in-process samples, and finished products

• Identifying and resolving quality issues

• Maintaining documentation and records

• Conducting audits and inspections

• Collaborating with other departments to improve quality and efficiency

Criteria for Uniformity of Dosage Unit

• Uniformity of weight and drug content in each dosage unit

• Acceptable range of variation in weight and drug content

• Ensuring consistent potency and efficacy of the drug

• Testing methods include weight variation test and content uniformity test

• Criteria varies depending on the type of drug and dosage form

pH is a measure of acidity or alkalinity of a solution. Environmental monitoring in microbiology is the process of monitoring the microbial contamination in the environment.

• pH is measured on a scale of 0-14, with 7 being neutral, below 7 acidic and above 7 alkaline

• Environmental monitoring in microbiology involves sampling and testing of air, water, surfaces, and personnel for microbial contamination

• The purpose of environmental monitoring is to identify potential sources of co...read more

The material safety in my working area is ensured through strict adherence to safety protocols and regular inspections.

• Strict adherence to safety protocols

• Regular inspections to identify and address any potential hazards

• Proper storage and handling of materials

• Use of personal protective equipment (PPE)

• Training and awareness programs for employees

Dissolution criteria refers to the amount of drug substance that should dissolve in a specified time period.

• It is a measure of drug release from a dosage form.

• It is important for ensuring the drug is being absorbed properly.

• The criteria varies depending on the type of drug and dosage form.

• For example, immediate-release tablets should dissolve at least 80% in 30 minutes.

• Slow-release tablets may have a longer dissolution time.

Saliva pH range is typically between 6.2 and 7.6, while water pH range is generally between 6.5 and 8.5.

• Saliva pH range: 6.2 - 7.6

• Water pH range: 6.5 - 8.5

QA (Quality Assurance) focuses on preventing defects, while QC (Quality Control) focuses on identifying and fixing defects.

• QA is a proactive process that ensures quality standards are met throughout the entire development process.

• QC is a reactive process that involves inspecting and testing the final product to identify defects.

• QA involves activities like creating test plans, conducting reviews, and implementing quality standards.

• QC involves activities like conducting inspect...read more

I have performed the microbiological test the most.

• Microbiological test is crucial in ensuring the safety and quality of products.

• Examples include testing for microbial contamination in food and pharmaceutical products.

• I have performed this test numerous times in my previous roles as a Quality Control Officer.

PP in pharmacy stands for Pharmaceutical Product.

• PP refers to the final product that is manufactured by a pharmaceutical company.

• It includes all the ingredients and excipients that are necessary for the product to be effective.

• PP is subject to strict quality control measures to ensure its safety and efficacy.

• Examples of PP include tablets, capsules, injections, and creams.

Dose of any drug for children can be calculated based on their weight and age.

• Calculate the child's weight in kilograms

• Determine the appropriate dosage based on the child's age and weight

• Consult drug reference guides or a pharmacist for specific dosing information

• Adjust the dosage based on the child's response to the medication

• Consider any potential side effects or drug interactions

Air monitoring is the process of measuring and analyzing the quality of air. Gram+ ve and gram - ve refer to different types of bacteria based on their cell wall structure.

• Air monitoring involves collecting air samples and analyzing them for pollutants, allergens, and other contaminants.

• Gram+ ve bacteria have a thick peptidoglycan layer in their cell wall, while gram - ve bacteria have a thinner peptidoglycan layer.

• Gram+ ve bacteria retain the crystal violet stain in the Gram...read more

GMP stands for Good Manufacturing Practice. It is a set of guidelines and regulations that ensure the quality and safety of pharmaceutical products.

• GMP is a system that ensures pharmaceutical products are consistently produced and controlled according to quality standards.

• It covers all aspects of production, including facilities, equipment, personnel, documentation, and processes.

• GMP guidelines are enforced by regulatory authorities to protect public health and ensure product...read more

UV/Vis spectrometry measures the absorption of light in the UV and visible range to identify and quantify substances.

• UV/Vis spectrometry is based on the principle that molecules absorb light in the UV and visible range.

• The range of UV light is typically 200-400 nm, while the range of visible light is 400-700 nm.

• UV/Vis spectrometry is commonly used in analytical chemistry to identify and quantify substances in a sample.

• For example, it can be used to measure the concentration o...read more

PIOC stands for Process Input Output Control and POC stands for Process Output Control.

• PIOC is a system that monitors and controls the input and output of a manufacturing process.

• POC is a system that monitors and controls the output of a manufacturing process.

• PIOC ensures that the inputs to a process are within acceptable limits.

• POC ensures that the outputs of a process meet the required specifications.

• Both PIOC and POC are important for maintaining quality control in manufac...read more

ALCOA and ALCOA+ are guidelines for data integrity in pharmaceutical industry.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA+ adds the principles of Complete, Consistent, Enduring, and Available.

• These guidelines ensure that data is reliable, accurate, and can be traced back to its source.

• For example, all data entries must be dated and signed by the person who made them.

• ALCOA+ also requires that data is complete and consistent throughout ...read more

Hard and soft gelatin capsules are two types of capsules used for oral medication.

• Hard gelatin capsules are made of two pieces that fit together and are filled with dry or powdered medication.

• Soft gelatin capsules are made of a single piece and are filled with liquid or semi-solid medication.

• Hard capsules dissolve slowly in the stomach, while soft capsules dissolve quickly.

• Soft capsules are often used for oil-based medications, while hard capsules are used for dry or powdered...read more

Stages of process validation include process design, process qualification, and continued process verification.

• Process design involves defining the process parameters and identifying critical process parameters.

• Process qualification involves testing the process to ensure it consistently produces quality products.

• Continued process verification involves monitoring the process to ensure it remains in a state of control.

• Examples of process validation include sterilization process...read more

OOS stands for Out of Specification.

• OOS refers to a result that falls outside the predetermined acceptance criteria or specification limits.

• It can occur during testing, manufacturing, or packaging processes.

• OOS results must be investigated to determine the root cause and appropriate corrective actions.

• Examples include a product failing a potency test or a package not meeting weight requirements.

Criteria for blend uniformity in pharmaceutical manufacturing

• Blend uniformity is the degree to which the API and excipients are evenly distributed throughout the blend

• Criteria for blend uniformity include acceptance criteria for assay and content uniformity

• Sampling plan and testing method should be appropriate for the blend characteristics

• Blend uniformity testing should be performed at appropriate stages of manufacturing process

• Examples of blend uniformity tests include strat...read more

Dissolution test measures the rate of drug release from a dosage form while desentigration test measures the time taken for a dosage form to break down into smaller particles.

• Dissolution test measures the amount of drug released from a dosage form over time

• Desentigration test measures the time taken for a dosage form to break down into smaller particles

• Both tests are important in ensuring the quality and efficacy of a drug

• For example, a tablet that does not dissolve properly ...read more

System suitability parameters are used to ensure that the HPLC system is working properly.

• System suitability parameters include resolution, tailing factor, and peak symmetry.

• These parameters are measured using a standard sample before running actual samples.

• Acceptance criteria for each parameter should be established and documented.

• If the system fails to meet the acceptance criteria, corrective action should be taken before running samples.

• Examples of corrective action includ...read more

BP stands for blood pressure. Human anatomy is the study of the structure and organization of the human body.

• BP is a measure of the force of blood against the walls of arteries

• Human anatomy includes the study of bones, muscles, organs, and tissues

• An understanding of human anatomy is important for medical professionals

• Examples of human anatomy include the heart, lungs, brain, and digestive system

Parameters for method validation include accuracy, precision, specificity, linearity, range, and robustness.

• Accuracy: how close the measured value is to the true value

• Precision: how reproducible the results are

• Specificity: how well the method measures only the analyte of interest

• Linearity: how well the method produces results that are proportional to the analyte concentration

• Range: the concentration range over which the method is accurate and precise

• Robustness: how well the m...read more

There are 11 systems in the human body, each with a specific function.

• The circulatory system pumps blood throughout the body.

• The respiratory system helps us breathe.

• The digestive system breaks down food and absorbs nutrients.

• The nervous system controls and coordinates body functions.

• The endocrine system produces hormones that regulate bodily functions.

• The immune system defends against infections and diseases.

• The lymphatic system helps remove waste and toxins from the body.

• The...read more

MLT stands for Medical Laboratory Technician. Gram staining is a laboratory technique used to differentiate bacterial species into two groups based on the physical and chemical properties of their cell walls.

• MLT is a healthcare professional who performs laboratory tests and analyses on patient samples.

• They work under the supervision of a medical technologist or pathologist.

• Examples of tests performed by MLTs include blood tests, urinalysis, and microbiology cultures.

• Gram stai...read more

Allergens are substances that can cause an allergic reaction in individuals.

• Allergens are typically proteins or glycoproteins.

• Common examples of allergens include pollen, dust mites, pet dander, certain foods (e.g., peanuts, shellfish), insect venom, and certain medications (e.g., penicillin).

• Allergens can trigger various allergic reactions, such as sneezing, itching, hives, difficulty breathing, and anaphylaxis.

• Identifying and avoiding allergens is important for individuals ...read more

Process validation is the documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

• Process validation is a critical component of quality assurance in manufacturing.

• It involves establishing documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

• Process validation typically involves three stages...read more

Pharmaceutical industry involves research, development, manufacturing, and distribution of drugs and medicines.

• Pharmaceutical industry is highly regulated by government agencies such as FDA

• It involves extensive research and development to create new drugs and improve existing ones

• Manufacturing of drugs requires strict adherence to quality control standards

• Distribution of drugs involves complex supply chain management

• Examples of pharmaceutical companies include Pfizer, Johnson...read more