Prepare for Pharmaceutics II with MCQs covering advanced topics like drug formulation, manufacturing processes, and quality control. Strengthen your understanding and improve your exam performance.
What is the main purpose of mixing in pharmaceutical processes?
A) To blend gases only
B) To enhance the flavor of products
C) To achieve a uniform distribution of components
D) To increase the volume of the product
Answer: C
Which equipment is used for the mixing of powders on a large scale?
A) Silverson Homogenizer
B) V-Type Mixer
C) Hammer Mill
D) Vacuum Tray Dryer
Answer: B
What is the process of reducing particle size in pharmaceuticals called?
A) Mixing
B) Drying
C) Size reduction
D) Filtration
Answer: C
Which method is commonly used for tablet manufacturing?
A) Dry granulation
B) Freeze-drying
C) Steam sterilization
D) Percolation
Answer: A
What type of dosage form is a gel considered?
A) Liquid
B) Solid
C) Semi-solid
D) Gaseous
Answer: C
The primary purpose of preservatives in pharmaceutical formulations is to:
A) Enhance flavor
B) Improve appearance
C) Prevent microbial growth
D) Increase solubility
Answer: C
Which equipment is used to achieve fine grinding in the size reduction process?
A) Ball Mill
B) Vacuum Tray Dryer
C) V-Type Mixer
D) Falling Film Evaporator
Answer: A
Drying is primarily used to remove which component from a product?
A) Gases
B) Solvent
C) Particles
D) Air
Answer: B
Which drying equipment is suitable for temperature-sensitive products?
A) Belt Dryer
B) V-Type Mixer
C) Vacuum Tray Dryer
D) Ball Mill
Answer: C
In the filtration process, solids are separated from liquids using a:
A) Heating element
B) Centrifugal force
C) Porous medium
D) Evaporator
Answer: C
What is a key advantage of tablets as a dosage form?
A) Better taste than syrups
B) Enhanced stability compared to liquids
C) Requires refrigeration
D) Easier to manufacture than capsules
Answer: B
The ‘wet granulation’ method involves:
A) Heating without solvents
B) Mixing dry powders directly
C) Adding a liquid to form a damp mass
D) Evaporation under reduced pressure
Answer: C
Which excipient is used as a lubricant in tablet formulation?
A) Lactose
B) PVP
C) Talc
D) MCC
Answer: C
Capsules are generally made using which material for the shell?
A) Plastic
B) Gelatin
C) Metal
D) Glass
Answer: B
For which type of semisolid dosage form is the fusion method used in manufacturing?
A) Capsules
B) Syrups
C) Ointments
D) Tablets
Answer: C
Which of the following is a water-in-oil type of emulsion?
A) Cream
B) Syrup
C) Powder
D) Gel
Answer: A
What is the role of a suspending agent in a pharmaceutical suspension?
A) Improve taste
B) Stabilize emulsions
C) Increase viscosity to keep particles suspended
D) Reduce particle size
Answer: C
Buffers are used in pharmaceutical products to:
A) Change the color
B) Control pH levels
C) Increase viscosity
D) Add flavor
Answer: B
Which substance is commonly used as an antioxidant in pharmaceuticals?
A) Acacia
B) Ascorbic acid
C) Talc
D) Gelatin
Answer: B
Which preservative is frequently added to pharmaceutical products to prevent microbial growth?
A) Sodium chloride
B) Benzoic acid
C) Acetone
D) Citric acid
Answer: B
Which of the following is commonly used as a solubilizer in oral formulations?
A) Talc
B) Alcohol
C) Zinc oxide
D) Gelatin
Answer: B
Sodium carboxymethylcellulose is an example of which type of agent?
A) Lubricant
B) Antioxidant
C) Suspending agent
D) Preservative
Answer: C
The primary function of stabilizers in pharmaceutical products is to:
A) Increase sweetness
B) Inhibit unwanted reactions
C) Reduce viscosity
D) Change the color of the product
Answer: B
Which buffer system would be used to maintain a neutral pH?
A) Sodium citrate-citric acid
B) Sodium acetate-acetic acid
C) Boric acid-sodium borate
D) Potassium phosphate
Answer: D
What is the role of benzoic acid in pharmaceutical formulations?
A) Sweetening agent
B) Solvent
C) Preservative
D) Stabilizer
Answer: C
Which of the following is a requirement for packaging materials?
A) They should be costly
B) They must react with the product
C) They should be FDA approved
D) They should impart taste to the product
Answer: C
The primary function of a closure in packaging is to:
A) Allow easy transport
B) Seal the container and exclude contaminants
C) Increase the weight of the package
D) Serve as an identification label
Answer: B
Which packaging material is known for its strength and impermeability?
A) Rubber
B) Glass
C) Paper
D) Plastic
Answer: B
A common disadvantage of using glass as a packaging material is its:
A) Low cost
B) Flexibility
C) Fragility
D) Impermeability
Answer: C
Which type of rubber is preferred for multi-dose injection packaging due to its resealing properties?
A) Synthetic rubber
B) Hard rubber
C) Natural rubber
D) Recycled rubber
Answer: C
Cartons made of cellulose fiber are primarily used for:
A) Injectables
B) Liquid storage
C) Secondary protection and display
D) Sterilization
Answer: C
Pharmaceutical products should be stored in conditions that are:
A) Uncontrolled
B) Dirty and damp
C) Clean, dry, and within specified temperature and humidity limits
D) Always refrigerated
Answer: C
What is the purpose of monitoring temperature and humidity in storerooms?
A) To increase product shelf life
B) To comply with legal regulations
C) To ensure proper storage conditions
D) To prevent theft
Answer: C
Which products require special storage areas with additional safety measures?
A) Tablets
B) Ointments
C) Radioactive materials and dangerous drugs
D) Vitamin supplements
Answer: C
In Good Storage Practice, what should be done with broken or damaged items?
A) Store with usable stock
B) Sell at a discounted price
C) Store separately and dispose of properly
D) Use for training purposes only
Answer: C
A system should be in place to ensure that pharmaceutical products are distributed based on:
A) Their appearance
B) First in, first out (FIFO) principle
C) Highest price first
D) Random order
Answer: B
The primary goal of quality control in pharmaceuticals is to ensure:
A) Low production cost
B) Aesthetics of the product
C) Safety and therapeutic effectiveness of products
D) Speed of manufacturing
Answer: C
Which stage involves testing raw materials for quality in pharmaceutical quality control?
A) First stage
B) Second stage
C) Third stage
D) Final stage
Answer: A
Which organization provides guidelines for quality assurance in pharmaceuticals worldwide?
A) FDA
B) WHO
C) USP
D) EPA
Answer: B
A critical aspect of quality control is to ensure that all drugs meet:
A) Financial requirements
B) Aesthetic criteria
C) Established specifications of identity, purity, and strength
D) Market trends
Answer: C
The quality control unit is responsible for approving products for:
A) Testing only
B) Marketing only if they meet quality standards
C) Distribution without testing
D) Storage
Answer: B
At which stage is the quality of the final product monitored after it has been marketed?
A) First stage
B) Second stage
C) Third stage
D) Final stage
Answer: D
Which method is commonly used for sterilizing heat-sensitive materials?
A) Dry-heat sterilization
B) Filtration
C) Autoclaving
D) Exposure to radiation
Answer: B
The autoclave sterilization method uses:
A) Dry heat
B) Chemical gas
C) Steam under pressure
D) Ultraviolet light
Answer: C
Which sterilization method involves heating products to high temperatures without moisture?
A) Steam sterilization
B) Filtration
C) Dry-heat sterilization
D) Gas sterilization
Answer: C
Gas sterilization is most suitable for materials that:
A) Can withstand high temperatures
B) Are sensitive to moisture and heat
C) Are non-reactive to radiation
D) Have low thermal conductivity
Answer: B
The main goal of sterilization is to:
A) Increase product viscosity
B) Enhance the color of the product
C) Eliminate all microorganisms, including spores
D) Reduce manufacturing costs
Answer: C
The primary purpose of documentation in pharmaceuticals is to:
A) Reduce paperwork
B) Ensure there is no misinterpretation and maintain traceability
C) Increase the cost of manufacturing
D) Decrease storage space
Answer: B
Batch records are essential because they:
A) Determine the selling price of the product
B) Allow tracing the history of each batch
C) Are kept only for aesthetic reasons
D) Minimize production time
Answer: B
Standard Operating Procedures (SOPs) should:
A) Be flexible and allow changes without documentation
B) Be strictly followed and deviations thoroughly investigated
C) Be used only when needed
D) Replace the need for any other form of documentation
Answer: B
Good documentation practices include:
A) Keeping documents only in electronic form
B) Maintaining accurate and detailed records of all activities
C) Using shorthand in records for brevity
D) Storing all records indefinitely
Answer: B
Which of the following documents is crucial for ensuring compliance with product specifications?
A) Marketing reports
B) Standard Operating Procedures
C) Employee attendance logs
D) Financial audits
Answer: B
Rheology is the study of:
A) Chemical composition
B) Flow and deformation of matter
C) Thermal conductivity
D) Electrical properties
Answer: B
Which instrument is commonly used to measure viscosity in rheology?
A) Brookfield viscometer
B) Autoclave
C) Hammer mill
D) Falling film evaporator
Answer: A
Rheological measurements are important for determining the:
A) pH of solutions
B) Stability of suspensions and emulsions
C) Color of a product
D) Solubility of powders
Answer: B
In a Brookfield viscometer, the resistance to movement of a spindle in a fluid measures:
A) Temperature changes
B) Surface tension
C) Viscosity
D) Density
Answer: C
A higher viscosity value indicates that the fluid is:
A) More fluid and flows easily
B) Less fluid and flows less easily
C) Completely solid
D) Unaffected by temperature changes
Answer: B
The most common liquid dosage form in pharmaceuticals is:
A) Tablets
B) Syrups
C) Powders
D) Ointments
Answer: B
Syrups generally contain a high concentration of:
A) Oils
B) Alcohols
C) Sugars
D) Proteins
Answer: C
Which method of syrup preparation is suitable for heat-sensitive ingredients?
A) Hot method
B) Percolation
C) Agitation without heating
D) Filtration
Answer: C
Preservatives are added to syrups to:
A) Increase viscosity
B) Enhance taste
C) Prevent microbial growth
D) Change color
Answer: C
Which component is commonly used to adjust the sweetness of syrups?
A) Talc
B) Glycerin
C) Sodium benzoate
D) Sucrose
Answer: D
Ointments are classified as:
A) Solid dosage forms
B) Liquid dosage forms
C) Semisolid dosage forms
D) Gaseous dosage forms
Answer: C
The fusion method of preparing ointments involves:
A) Mixing ingredients without heating
B) Melting ingredients in descending order of their melting points
C) Grinding ingredients with a base
D) Using a vacuum to remove air bubbles
Answer: B
Creams are classified based on their emulsion type as either:
A) Gels and pastes
B) Water-in-oil or oil-in-water
C) Solid or liquid emulsions
D) Syrups and solutions
Answer: B
Which method is commonly used to prepare a primary emulsion in creams?
A) Agitation method
B) Dry gum method
C) Evaporation method
D) Autoclaving
Answer: B
The key difference between ointments and creams is that creams are typically:
A) Thicker and less water-soluble
B) More fluid and water-based
C) Solid and non-spreadable
D) Used only for oral administration
Answer: B
Parenteral dosage forms are administered:
A) Orally
B) Topically
C) By injection
D) Via inhalation
Answer: C
Sterility is a key requirement for parenteral products because:
A) They are ingested orally
B) They bypass the body’s natural barriers
C) They are always used topically
D) They have no risk of contamination
Answer: B
Which of the following is a common method used for sterilizing parenteral products?
A) Filtration
B) Mixing
C) Evaporation
D) Sedimentation
Answer: A
The primary requirement for a parenteral solution is that it must be:
A) Colorful
B) Sterile and pyrogen-free
C) Viscous
D) Sweetened
Answer: B
What is the typical pH range for most parenteral solutions?
A) 0-2
B) 3-5
C) 7-7.5
D) 10-12
Answer: C
Which of the following is important for the storage of pharmaceutical products?
A) Keeping them exposed to sunlight
B) Storing in a clean, dry environment
C) Always refrigerating products
D) Storing with hazardous chemicals
Answer: B
What should be done if a pharmaceutical product is found to be expired?
A) Repackage and sell it
B) Discard it immediately
C) Store it with usable products
D) Use it for training purposes
Answer: B
The principle of storing pharmaceutical products based on ‘First Expired, First Out’ is known as:
A) First in, first out (FIFO)
B) Last in, first out (LIFO)
C) First expired, first out (FEFO)
D) Last expired, first out (LEFO)
Answer: C
What type of monitoring is required for storerooms to ensure proper conditions?
A) Daily inspection of cleanliness only
B) Temperature and humidity monitoring
C) Checking product colors regularly
D) Random sampling of product weights
Answer: B
In pharmaceutical storage, controlled substances should be stored:
A) In general stock areas
B) In secure, dedicated areas with additional safety measures
C) Near flammable materials
D) On open shelves
Answer: B
Industrial quality control in pharmaceuticals focuses on:
A) Enhancing product color
B) Meeting established specifications of identity, purity, and strength
C) Reducing production costs
D) Increasing manufacturing speed
Answer: B
The quality of pharmaceutical products is assessed through:
A) Visual inspection only
B) Laboratory testing and documentation
C) Price comparison with competitors
D) Marketing surveys
Answer: B
Which of the following ensures that manufacturing processes meet quality standards?
A) Random quality checks without documentation
B) Continuous monitoring and validation of procedures
C) Relying solely on the final product testing
D) Ignoring deviations from standard procedures
Answer: B
Which stage of quality control includes checking the final product for compliance before marketing?
A) Initial stage
B) In-process stage
C) Final stage
D) Post-marketing stage
Answer: C
The purpose of validating a sterilization process in quality control is to:
A) Shorten the manufacturing time
B) Verify that all microorganisms are effectively destroyed
C) Increase the temperature used
D) Reduce the cost of production
Answer: B
Documentation in the pharmaceutical industry serves to:
A) Increase paperwork for employees
B) Ensure compliance with regulatory standards
C) Make products more appealing
D) Replace the need for quality control
Answer: B
Standard Operating Procedures (SOPs) are important because they:
A) Allow for flexibility in processes
B) Provide detailed instructions for tasks and processes
C) Are optional in quality control
D) Can be modified without approval
Answer: B
Batch Manufacturing Records (BMR) should be kept for:
A) One month after production
B) Until the product is sold
C) At least one year after the product’s expiry date
D) Indefinitely
Answer: C
Which of the following must be documented in a pharmaceutical company?
A) All marketing strategies
B) Manufacturing processes, testing results, and SOPs
C) Employee personal details
D) Only the final product specifications
Answer: B
Good documentation practices require that documents are:
A) Kept only in electronic form
B) Written clearly and signed by authorized personnel
C) Stored for a minimum of five years regardless of content
D) Allowed to be modified without tracking changes
Answer: B
Antioxidants are added to pharmaceutical products primarily to:
A) Change the product’s appearance
B) Enhance the therapeutic effect
C) Prevent oxidation of active ingredients
D) Lower the product’s viscosity
Answer: C
Commonly used solubilizers in oral formulations include:
A) Talc and zinc oxide
B) Alcohol and glycerin
C) Titanium dioxide
D) Silicone oil
Answer: B
The use of buffers in pharmaceutical products helps to:
A) Alter the color of the formulation
B) Maintain a stable pH
C) Increase the density of the solution
D) Enhance the fragrance
Answer: B
Which agent is commonly used as a preservative to prevent microbial contamination?
A) Sucrose
B) Sodium chloride
C) Sodium benzoate
D) Glycerin
Answer: C
Suspending agents in pharmaceutical suspensions function to:
A) Prevent oxidation
B) Increase viscosity and keep particles suspended
C) Change the flavor
D) Act as primary emulsifiers
Answer: B
Evaporation in pharmaceuticals is used to:
A) Increase the volume of a solution
B) Concentrate a solution by removing the solvent
C) Add moisture to a product
D) Mix different liquids
Answer: B
Which type of evaporator is commonly used for heat-sensitive materials?
A) Vacuum tray dryer
B) Falling film evaporator
C) Belt dryer
D) Hammer mill
Answer: B
In a natural circulation evaporator, circulation is caused by:
A) Density differences due to heating
B) Mechanical stirring
C) Centrifugal force
D) External pressure changes
Answer: A
The boiling point of a solution in an evaporator is usually:
A) Lower than the pure solvent
B) Higher than the pure solvent
C) The same as the pure solvent
D) Not affected by concentration
Answer: B
What is a primary application of evaporation in the pharmaceutical industry?
A) Color enhancement
B) Solution concentration
C) Product mixing
D) Filtration of solids
Answer: B
The main purpose of mixing in pharmaceutical manufacturing is to:
A) Increase the product’s weight
B) Ensure a uniform distribution of ingredients
C) Reduce particle size
D) Increase the temperature of the mixture
Answer: B
Which type of mixer is used for large-scale powder mixing?
A) Silverson homogenizer
B) V-Type mixer
C) Vacuum tray dryer
D) Falling film evaporator
Answer: B
Mixing in liquid formulations often involves:
A) Centrifugation
B) Shear forces
C) Drying techniques
D) Size reduction
Answer: B
The efficiency of a V-Type mixer largely depends on:
A) The temperature of the mixture
B) The speed of rotation
C) The color of the components
D) The volume of the mixture
Answer: B
In mixing processes, connective movement refers to:
A) The movement of particles through vibration
B) Flowing motion within the mixture
C) Chemical changes due to mixing
D) Decreasing particle size through grinding
Answer: B
Filtration is used in the pharmaceutical industry to:
A) Separate solids from liquids
B) Evaporate solvents
C) Increase the volume of a liquid
D) Change the chemical composition
Answer: A
A vertical pressure leaf filter is used for filtering:
A) Gases only
B) Liquids with suspended solids
C) Dry powders
D) Airborne contaminants
Answer: B
The tubular centrifuge filter works by:
A) Applying gravitational forces to separate liquids
B) Using centrifugal force to separate liquids based on their density
C) Mixing liquids together for homogenization
D) Heating to evaporate the solvent
Answer: B
In the filtration process, what is the role of the porous medium?
A) To increase the solution’s temperature
B) To allow liquids to pass while retaining solids
C) To add chemicals to the solution
D) To evaporate the liquid content
Answer: B
Filtration is commonly used in which stage of pharmaceutical manufacturing?
A) Packaging
B) Quality control testing
C) Sterilization
D) Storage
Answer: C
Size reduction in pharmaceuticals is also known as:
A) Filtration
B) Comminution
C) Evaporation
D) Mixing
Answer: B
Which equipment is used for size reduction through impact and attrition?
A) Vacuum tray dryer
B) Ball mill
C) Falling film evaporator
D) V-Type mixer
Answer: B
The main advantage of reducing particle size in pharmaceuticals is:
A) Increased solubility and faster dissolution
B) Lower manufacturing costs
C) Easier handling and packaging
D) Improved product color
Answer: A
In a hammer mill, the material is pulverized by:
A) Centrifugal force
B) Swinging hammers striking the material
C) High-temperature heating
D) Chemical reactions
Answer: B
Size reduction is crucial for:
A) Enhancing the product’s color
B) Improving the dissolution rate of solid dosage forms
C) Increasing the temperature of the product
D) Packaging the final product
Answer: B
Drying is used in the pharmaceutical industry to:
A) Increase the moisture content of products
B) Remove water or solvents from a product
C) Mix different ingredients
D) Reduce the viscosity of liquids
Answer: B
Which drying equipment is most suitable for heat-sensitive materials?
A) Belt dryer
B) Vacuum tray dryer
C) V-Type mixer
D) Ball mill
Answer: B
The belt dryer is commonly used for drying materials that are:
A) High in moisture content
B) Insoluble in water
C) In the form of granules, pieces, or strips
D) Gaseous at room temperature
Answer: C
Vacuum drying is particularly useful for substances that are:
A) High in water content and stable at high temperatures
B) Temperature-sensitive and hygroscopic
C) Insoluble in organic solvents
D) Non-reactive to air exposure
Answer: B
During the drying process, the source of heat can be provided by:
A) Filtration
B) Chemical reactions
C) Electric heaters or steam
D) Centrifugal force
Answer: C
Quality control testing ensures that pharmaceutical products:
A) Meet safety and efficacy standards
B) Are the cheapest on the market
C) Have the longest shelf life possible
D) Are packaged in attractive containers
Answer: A
Which of the following is a common test for tablet quality control?
A) pH measurement
B) Hardness testing
C) Viscosity testing
D) Color comparison
Answer: B
The disintegration test for tablets measures:
A) The tablet’s appearance after storage
B) The time it takes for the tablet to break apart in a specified fluid
C) The color stability of the tablet
D) The weight of the tablet before and after testing
Answer: B
Which parameter is checked during the dissolution testing of a tablet?
A) Surface area of the tablet
B) Rate and extent of drug release in a liquid medium
C) Electrical conductivity of the medium
D) Color of the liquid after testing
Answer: B
In quality control, an assay is used to:
A) Assess the physical appearance of a drug
B) Determine the content or potency of an active ingredient
C) Test for microbial contamination only
D) Measure the weight of the final product
Answer: B
A key function of pharmaceutical packaging is to:
A) Increase the product’s weight
B) Provide protection and containment
C) Reduce the cost of production
D) Enhance the product’s color
Answer: B
The most common type of closure used to protect against moisture and contaminants is:
A) Paper seal
B) Rubber stopper
C) Plastic cap with liner
D) Glass cover
Answer: C
Blister packs are commonly used for packaging:
A) Liquids
B) Solid dosage forms like tablets and capsules
C) Aerosols
D) Injectable solutions
Answer: B
Which of the following materials is commonly used to make primary containers for parenteral products?
A) Glass
B) Wood
C) Aluminum
D) Cardboard
Answer: A
The term ‘tamper-evident packaging’ refers to packaging that:
A) Is easy to open
B) Shows signs of being opened or altered
C) Is used only for solid dosage forms
D) Requires refrigeration
Answer: B
Preservatives are added to pharmaceutical products primarily to:
A) Alter the pH of the product
B) Prevent the growth of microorganisms
C) Enhance the color
D) Increase the viscosity
Answer: B
Antioxidants prevent which type of degradation in pharmaceutical products?
A) Thermal degradation
B) Chemical oxidation
C) Microbial contamination
D) Physical changes
Answer: B
What is the purpose of using solubilizers in liquid formulations?
A) To increase the temperature of the solution
B) To improve the solubility of hydrophobic substances
C) To enhance the taste of the product
D) To decrease the viscosity
Answer: B
Which substance acts as both a suspending agent and a thickener in pharmaceutical suspensions?
A) Talc
B) Xanthan gum
C) Alcohol
D) Glycerin
Answer: B
Buffers are used in pharmaceutical formulations to:
A) Change the viscosity
B) Maintain a stable pH
C) Add color
D) Enhance the fragrance
Answer: B
Good Manufacturing Practices (GMP) are primarily concerned with:
A) Marketing strategies
B) The safety, quality, and efficacy of pharmaceutical products
C) Reducing production costs
D) Increasing product aesthetics
Answer: B
Which of the following is an essential requirement of GMP?
A) Frequent product recalls
B) Clear and accurate documentation
C) Ignoring deviations from standard procedures
D) Using only manual equipment
Answer: B
GMP regulations ensure that pharmaceutical manufacturing facilities are:
A) Located in residential areas
B) Suitable for maintaining sanitary conditions
C) Always fully automated
D) Used for multiple purposes
Answer: B
Personnel involved in GMP must be:
A) Highly experienced in marketing
B) Trained in hygiene and proper procedures
C) Exempt from following written procedures
D) Responsible only for documenting product defects
Answer: B
GMP emphasizes the importance of:
A) Unregulated processes
B) Consistency and control in manufacturing
C) Using the cheapest available materials
D) Flexibility in product quality standards
Answer: B
Stability testing in pharmaceuticals is performed to:
A) Determine the shelf life of a product
B) Reduce production time
C) Enhance the product’s color
D) Increase packaging costs
Answer: A
A key factor affecting the stability of pharmaceutical products is:
A) The packaging color
B) Temperature, humidity, and light exposure
C) The product’s weight
D) Storage in large quantities
Answer: B
Which type of stability testing assesses how the product responds to high temperature and humidity?
A) Long-term stability testing
B) Accelerated stability testing
C) Microbial stability testing
D) Physical stability testing
Answer: B
The expiration date of a pharmaceutical product is based on:
A) The initial manufacturing date
B) The results of stability testing
C) The marketing strategies of the company
D) The time taken to package the product
Answer: B
Chemical degradation in pharmaceuticals can lead to:
A) Enhanced drug efficacy
B) Loss of potency and potential toxicity
C) Increase in shelf life
D) More appealing product appearance
Answer: B
The main goal of a quality assurance system is to:
A) Minimize documentation
B) Ensure products are safe and effective for their intended use
C) Reduce the cost of raw materials
D) Speed up the production process
Answer: B
Quality assurance in the pharmaceutical industry is typically achieved through:
A) Random inspections without standards
B) Compliance with GMP and regulatory guidelines
C) Relying solely on the final product appearance
D) Flexible quality standards
Answer: B
In a QA system, deviations from standard procedures must be:
A) Ignored if the final product looks acceptable
B) Documented and thoroughly investigated
C) Encouraged to increase efficiency
D) Repeated without changes
Answer: B
Which of the following is part of a comprehensive quality assurance process?
A) Marketing reports
B) Equipment maintenance records
C) Employee travel expenses
D) Sales strategies
Answer: B
The role of quality assurance includes:
A) Setting flexible standards for each product
B) Monitoring and improving manufacturing processes continuously
C) Only assessing products post-marketing
D) Exempting new products from validation requirements
Answer: B
Documentation in the pharmaceutical industry must ensure that:
A) All procedures and results are recorded accurately
B) It can be easily modified without approval
C) It only includes financial reports
D) It is used solely for marketing purposes
Answer: A
Regulatory requirements in pharmaceuticals are set by organizations such as:
A) World Health Organization (WHO) and Food and Drug Administration (FDA)
B) Only local pharmacy councils
C) Private pharmaceutical companies
D) Marketing agencies
Answer: A
A Batch Manufacturing Record (BMR) should contain:
A) Details of financial transactions
B) Step-by-step documentation of the manufacturing process
C) Marketing strategies for the product
D) Details of employee work hours
Answer: B
Deviation reports are necessary when:
A) The final product does not meet the required specifications
B) There are no deviations in the process
C) Only during raw material acquisition
D) Regulatory inspections are not conducted
Answer: A
For compliance with regulatory standards, documents must be:
A) Kept confidential and not shared with authorities
