Mcqs
Mcqs
Great! Here are 20 MCQs for Good Manufacturing Practices (GMP), Good Storage Practices (GSP),
& Good Distribution Practices (GDP).
2. Good Manufacturing Practices (GMP), Good Storage Practices (GSP), & Good Distribution
Practices (GDP) (20 MCQs)
1. Which of the following is the main goal of Good Manufacturing Practices (GMP)? a) To
improve the quality of raw materials
b) To ensure the safety, quality, and efficacy of pharmaceuticals
c) To lower the production costs
d) To increase production speed
Answer: b) To ensure the safety, quality, and efficacy of pharmaceuticals
2. What does GSP (Good Storage Practices) primarily focus on? a) Ensuring drugs are
manufactured correctly
b) Maintaining safe and optimal conditions for drug storage
c) Reducing the cost of storage
d) Expediting drug distribution
Answer: b) Maintaining safe and optimal conditions for drug storage
3. Which of the following is a critical requirement of GMP? a) Proper labeling of products
b) Regular training of employees
c) Maintaining clean production areas
d) All of the above
Answer: d) All of the above
4. Which of the following does NOT fall under the scope of Good Distribution Practices
(GDP)? a) Ensuring proper temperature control during transport
b) Maintaining proper hygiene in warehouses
c) Securing medications in manufacturing plants
d) Ensuring the integrity of the product during transportation
Answer: c) Securing medications in manufacturing plants
5. The storage temperature for most pharmaceutical products should be: a) Below 5°C
b) Between 15°C to 25°C
c) Over 40°C
d) Between 5°C to 15°C
Answer: b) Between 15°C to 25°C
6. Which of the following is a key requirement for GMP in the pharmaceutical manufacturing
process? a) Use of high-quality ingredients
b) Use of well-trained staff
c) Properly validated equipment
d) All of the above
Answer: d) All of the above
7. What is the purpose of a cleanroom in GMP? a) To ensure that there are no contaminants in
the manufacturing process
b) To improve the aesthetic appeal of the factory
c) To increase worker productivity
d) To store finished products
Answer: a) To ensure that there are no contaminants in the manufacturing process
8. Which of the following best describes a critical aspect of GDP? a) Ensuring proper packaging
and labeling of medicines
b) Ensuring that medicines are delivered to the correct location on time
c) Maintaining consistent humidity levels during storage
d) All of the above
Answer: d) All of the above
9. Which of the following is a key factor in the design of pharmaceutical storage areas? a)
Accessibility for customers
b) Temperature and humidity control
c) Proximity to transportation routes
d) Cost reduction
Answer: b) Temperature and humidity control
10. Which of the following is required for ensuring GMP compliance in manufacturing
facilities? a) Written procedures and protocols for all processes
b) Unrestricted access to production areas for the public
c) Minimal documentation
d) Using only non-sterile equipment
Answer: a) Written procedures and protocols for all processes
11. Under GMP, the equipment used in manufacturing must be: a) Easy to use
b) Regularly cleaned and maintained
c) Left unattended for extended periods
d) Low-cost
Answer: b) Regularly cleaned and maintained
12. Which of the following is an essential part of Good Storage Practices (GSP)? a) Keeping
products in areas with high traffic
b) Ensuring controlled lighting conditions
c) Storing products based on expiry dates and batch numbers
d) Using only cardboard boxes for storage
Answer: c) Storing products based on expiry dates and batch numbers
13. Which of the following actions is critical in GMP for preventing cross-contamination? a)
Use of segregated areas for different types of products
b) Mixing different products together
c) Ignoring cleaning protocols
d) Storing raw materials in any available space
Answer: a) Use of segregated areas for different types of products
14. GDP ensures that: a) Drugs are distributed through appropriate channels
b) Drugs are manufactured in proper facilities
c) Drugs are approved by the government
d) All of the above
Answer: a) Drugs are distributed through appropriate channels
15. Which of the following is a major GMP requirement for personnel in pharmaceutical
manufacturing? a) Regular training on hygiene and operational procedures
b) Ability to work without supervision
c) Minimal interaction with raw materials
d) Limited communication with management
Answer: a) Regular training on hygiene and operational procedures
16. What is the primary objective of Good Distribution Practices (GDP)? a) To reduce the cost
of drugs during transportation
b) To ensure the quality and integrity of pharmaceutical products throughout the distribution
chain
c) To increase the shelf life of pharmaceutical products
d) To minimize the storage area for pharmaceutical products
Answer: b) To ensure the quality and integrity of pharmaceutical products throughout the
distribution chain
17. What is the role of humidity control in GSP? a) To protect the integrity of pharmaceutical
products that are sensitive to moisture
b) To enhance the fragrance of medicines
c) To speed up the aging process of drugs
d) To increase the volume of products stored
Answer: a) To protect the integrity of pharmaceutical products that are sensitive to moisture
18. Which of the following best describes the requirements for packaging in GDP? a) Packaging
should be designed to prevent contamination, degradation, and damage during transportation
b) Packaging can be simple and not provide adequate protection
c) Only aesthetic packaging is important
d) No packaging is required for drug distribution
Answer: a) Packaging should be designed to prevent contamination, degradation, and damage
during transportation
19. Which of the following must be included in the documentation for GMP compliance? a)
Procedures for cleaning and sanitation
b) Employee personal files
c) Financial audit reports
d) All of the above
Answer: a) Procedures for cleaning and sanitation
20. What is the primary concern when distributing pharmaceutical products under GDP
guidelines? a) Cost-effectiveness
b) Integrity of the product during transport and storage
c) Speed of delivery
d) The number of warehouses involved
Answer: b) Integrity of the product during transport and storage
Next, I’ll proceed with the Drug Licensing & Registration Process in Pakistan. Stay tuned!
1. Which of the following authorities is responsible for drug licensing and registration in
Pakistan? a) Ministry of Health
b) Drug Regulatory Authority of Pakistan (DRAP)
c) Pakistan Medical Association (PMA)
d) Federal Board of Revenue (FBR)
Answer: b) Drug Regulatory Authority of Pakistan (DRAP)
2. In Pakistan, a drug must be registered with DRAP before it can be: a) Advertised on TV
b) Imported, sold, or distributed
c) Sold at pharmacies without a prescription
d) Delivered to hospitals for clinical trials
Answer: b) Imported, sold, or distributed
3. What is the first step in the drug registration process in Pakistan? a) Submission of
application to DRAP
b) Clinical trials in the country
c) Payment of registration fees
d) Laboratory testing of the drug
Answer: a) Submission of application to DRAP
4. Which document is essential when submitting a drug registration application in Pakistan?
a) Clinical trial data
b) Tax clearance certificate
c) Certificate of origin
d) Drug safety report
Answer: c) Certificate of origin
5. What is required for the registration of a foreign drug in Pakistan? a) A letter from the
Ministry of Foreign Affairs
b) A copy of the product’s license from the exporting country
c) A market approval from WHO
d) A valid production facility license
Answer: b) A copy of the product’s license from the exporting country
6. Which of the following is a mandatory part of the registration process for a new drug in
Pakistan? a) Registration with WHO
b) Proof of efficacy and safety
c) Advertisement approval
d) Public opinion survey
Answer: b) Proof of efficacy and safety
7. What must pharmaceutical manufacturers provide to DRAP when registering a drug in
Pakistan? a) Production and storage facility details
b) Approval from the local police
c) Marketing strategy
d) Contract with suppliers
Answer: a) Production and storage facility details
8. How long does the drug registration process typically take in Pakistan? a) 3–6 months
b) 6–12 months
c) 1–2 years
d) Over 2 years
Answer: b) 6–12 months
9. What type of drug does the DRAP registration process apply to in Pakistan? a) Only over-
the-counter drugs
b) Only prescription drugs
c) All drugs, including over-the-counter and prescription drugs
d) Only herbal and alternative medicines
Answer: c) All drugs, including over-the-counter and prescription drugs
10. For a drug registration application, which of the following must be submitted regarding the
product’s label? a) Detailed labeling for all languages used in the region
b) A copy of the label in the proposed market
c) A certification of label accuracy from the Ministry of Foreign Affairs
d) No need for a label submission
Answer: b) A copy of the label in the proposed market
11. What is required for the re-registration of a drug in Pakistan? a) New clinical trials
b) Annual fee payment
c) Updated information on product safety and efficacy
d) Reapproval by WHO
Answer: c) Updated information on product safety and efficacy
12. Which of the following is a requirement for drug licensing in Pakistan? a) Compliance with
the Drugs Act 1976
b) Payment of drug manufacturing fees
c) A certificate of good manufacturing practices (GMP)
d) Both a and c
Answer: d) Both a and c
13. What happens if a drug does not comply with the registration requirements in Pakistan? a)
The drug will be granted temporary registration
b) The drug’s registration will be denied
c) The drug will be marketed with restricted usage
d) A fine will be imposed, but registration will proceed
Answer: b) The drug’s registration will be denied
14. Which of the following steps is necessary before a pharmaceutical company can import
drugs into Pakistan? a) Completing a clinical trial in Pakistan
b) Obtaining a Drug Import License from DRAP
c) Registering the drug in the company’s home country
d) No licensing is required
Answer: b) Obtaining a Drug Import License from DRAP
15. What is the role of clinical trials in the drug registration process in Pakistan? a) Clinical
trials are not required for registration
b) Clinical trials help prove the safety and efficacy of the drug
c) Clinical trials are required only for foreign drugs
d) Clinical trials are only needed for generics
Answer: b) Clinical trials help prove the safety and efficacy of the drug
16. What is required for a pharmaceutical company to distribute a newly registered drug in
Pakistan? a) A Distribution License from DRAP
b) A special marketing approval
c) Certification from WHO
d) A recommendation from the Ministry of Health
Answer: a) A Distribution License from DRAP
17. How does DRAP assess the safety of a drug during the registration process? a) By reviewing
market sales data
b) Through submission of safety and toxicity data
c) By conducting its own clinical trials
d) By consulting with international regulatory agencies only
Answer: b) Through submission of safety and toxicity data
18. Which of the following is a factor that DRAP considers when evaluating a drug registration
application in Pakistan? a) The drug's popularity in foreign markets
b) The clinical data showing that the drug is safe and effective
c) The drug's advertising campaign
d) The potential market size of the drug
Answer: b) The clinical data showing that the drug is safe and effective
19. What is the registration fee for drugs in Pakistan based on? a) The drug’s retail price
b) The drug’s production cost
c) The type of drug and the scale of its use
d) The geographical region of sale
Answer: c) The type of drug and the scale of its use
20. What does DRAP stand for? a) Drug Regulation and Approval Process
b) Drug Registration Authority of Pakistan
c) Drug Regulatory Authority of Pakistan
d) Drug Research and Approval Panel
Answer: c) Drug Regulatory Authority of Pakistan
Here are 20 MCQs for Mechanism of action, side effects, and contraindications of major drug
classes:
4. Mechanism of Action, Side Effects, and Contraindications of Major Drug Classes (20 MCQs)
1. Which of the following is the primary mechanism of action of NSAIDs (Nonsteroidal Anti-
inflammatory Drugs)? a) Blockage of dopamine receptors
b) Inhibition of cyclooxygenase (COX) enzymes
c) Activation of opioid receptors
d) Blockage of calcium channels
Answer: b) Inhibition of cyclooxygenase (COX) enzymes
2. Which of the following is a common side effect of ACE inhibitors (Angiotensin-Converting
Enzyme inhibitors)? a) Hypertension
b) Cough
c) Bradycardia
d) Weight loss
Answer: b) Cough
3. What is the mechanism of action of beta-blockers? a) Inhibition of calcium channels
b) Blockade of beta-adrenergic receptors
c) Inhibition of angiotensin II
d) Activation of muscarinic receptors
Answer: b) Blockade of beta-adrenergic receptors
4. Which of the following drugs is commonly used to treat bacterial infections by inhibiting
cell wall synthesis? a) Ciprofloxacin
b) Amoxicillin
c) Paracetamol
d) Fluoxetine
Answer: b) Amoxicillin
5. What is a contraindication for the use of ACE inhibitors? a) Asthma
b) Pregnancy
c) Liver disease
d) Diabetes mellitus
Answer: b) Pregnancy
6. Which class of drugs works by increasing the amount of serotonin available in the brain to
treat depression? a) SSRIs (Selective Serotonin Reuptake Inhibitors)
b) Benzodiazepines
c) Antipsychotics
d) Opioids
Answer: a) SSRIs (Selective Serotonin Reuptake Inhibitors)
7. Which of the following is a potential side effect of long-term corticosteroid use? a)
Hyperkalemia
b) Weight gain
c) Hypertension
d) Both b and c
Answer: d) Both b and c
8. What is the mechanism of action of proton pump inhibitors (PPIs)? a) Inhibition of histamine
receptors
b) Blocking the enzyme responsible for stomach acid production
c) Increasing gastric mucus secretion
d) Neutralizing stomach acid
Answer: b) Blocking the enzyme responsible for stomach acid production
9. Which of the following is a contraindication for using beta-blockers? a) Asthma
b) Hypotension
c) Anxiety disorders
d) Hypertension
Answer: a) Asthma
10. Which of the following is a common side effect of diuretics (e.g., furosemide)? a)
Hyperkalemia
b) Hypokalemia
c) Increased appetite
d) Drowsiness
Answer: b) Hypokalemia
11. What is the mechanism of action of anticoagulants such as warfarin? a) Inhibition of vitamin
K-dependent clotting factors
b) Direct activation of fibrinogen
c) Inhibition of platelet aggregation
d) Blocking thrombin receptors
Answer: a) Inhibition of vitamin K-dependent clotting factors
12. Which drug class is primarily used to treat type 2 diabetes by improving insulin sensitivity?
a) Insulin analogs
b) Sulfonylureas
c) Biguanides (e.g., metformin)
d) Thiazolidinediones
Answer: c) Biguanides (e.g., metformin)
13. Which of the following side effects is commonly associated with opioid use? a) Diarrhea
b) Sedation
c) Increased heart rate
d) Increased urination
Answer: b) Sedation
14. What is the mechanism of action of antiepileptic drugs like phenytoin? a) Increasing
dopamine release
b) Blocking sodium channels in neurons
c) Enhancing GABAergic activity
d) Inhibiting serotonin reuptake
Answer: b) Blocking sodium channels in neurons
15. Which of the following is a contraindication for using nonsteroidal anti-inflammatory drugs
(NSAIDs)? a) Asthma
b) Gastric ulcers
c) Hyperlipidemia
d) Pregnancy (third trimester)
Answer: b) Gastric ulcers
16. Which of the following drugs is used to reverse opioid overdose? a) Naloxone
b) Atropine
c) Diazepam
d) Naltrexone
Answer: a) Naloxone
17. Which class of drugs is used to treat hypertension by inhibiting the enzyme that converts
angiotensin I to angiotensin II? a) Angiotensin receptor blockers (ARBs)
b) Beta-blockers
c) ACE inhibitors
d) Calcium channel blockers
Answer: c) ACE inhibitors
18. Which of the following side effects is commonly associated with the use of selective
serotonin reuptake inhibitors (SSRIs)? a) Weight gain
b) Sexual dysfunction
c) Insomnia
d) Both b and c
Answer: d) Both b and c
19. Which of the following drugs is used to treat infections caused by fungi by inhibiting
ergosterol synthesis? a) Amphotericin B
b) Ciprofloxacin
c) Metronidazole
d) Erythromycin
Answer: a) Amphotericin B
20. What is a common side effect of calcium channel blockers like amlodipine? a) Diarrhea
b) Cough
c) Edema (swelling)
d) Rash
Answer: c) Edema (swelling)
Next, I'll proceed with the Essential Drugs List (WHO & Pakistan National List). Stay tuned!
Here are 20 MCQs for Essential Drugs List (WHO & Pakistan National List):
5. Essential Drugs List (WHO & Pakistan National List) (20 MCQs)
1. What is the primary purpose of the World Health Organization’s (WHO) Essential
Medicines List (EML)? a) To increase the cost of medicines
b) To ensure access to medicines for the most common diseases
c) To list only rare diseases' medications
d) To restrict access to certain drugs
Answer: b) To ensure access to medicines for the most common diseases
2. How often is the WHO Essential Medicines List updated? a) Every 5 years
b) Every 2 years
c) Every 10 years
d) As needed, typically every 2 years
Answer: d) As needed, typically every 2 years
3. Which of the following is considered an essential medicine according to the WHO Essential
Medicines List? a) Aspirin
b) Vitamin D
c) Acyclovir
d) Ketamine
Answer: a) Aspirin
4. Which body is responsible for maintaining and updating the National Essential Medicines
List in Pakistan? a) Ministry of Health
b) Drug Regulatory Authority of Pakistan (DRAP)
c) World Health Organization
d) Pakistan Medical Association
Answer: b) Drug Regulatory Authority of Pakistan (DRAP)
5. What is the criterion for a drug to be included in the WHO Essential Medicines List? a) The
drug must have a high cost
b) The drug must be effective, safe, and affordable
c) The drug must only treat rare diseases
d) The drug must be manufactured domestically
Answer: b) The drug must be effective, safe, and affordable
6. Which of the following categories of drugs are included in the WHO Essential Medicines
List? a) Life-saving drugs only
b) Drugs for all common diseases
c) Only vaccines
d) Only painkillers
Answer: b) Drugs for all common diseases
7. Which of the following is a key feature of the Essential Medicines List in Pakistan? a) It
includes only drugs available in Pakistan
b) It is aligned with the WHO EML, with necessary modifications for local needs
c) It is updated every 10 years
d) It is focused solely on herbal medicines
Answer: b) It is aligned with the WHO EML, with necessary modifications for local needs
8. Which of the following is NOT typically included in the WHO Essential Medicines List? a)
Anticancer drugs
b) Antibiotics for common infections
c) Antihypertensive drugs
d) Experimental drugs
Answer: d) Experimental drugs
9. Which of the following is a benefit of the Essential Medicines List? a) It ensures that the most
commonly needed medicines are universally available
b) It promotes the use of only branded medications
c) It reduces the availability of generics
d) It limits access to essential medical treatments
Answer: a) It ensures that the most commonly needed medicines are universally available
10. Which class of medications is commonly found on the Essential Medicines List for
managing chronic conditions like hypertension? a) Calcium channel blockers
b) Anticancer agents
c) Antihistamines
d) Antifungals
Answer: a) Calcium channel blockers
11. What is the role of generic drugs on the Essential Medicines List? a) They are excluded due
to safety concerns
b) They provide affordable alternatives to brand-name medications
c) They are required to be imported
d) They are restricted to rare conditions only
Answer: b) They provide affordable alternatives to brand-name medications
12. Which of the following categories is NOT generally included in the Essential Medicines
List? a) Antimicrobials
b) Pain management drugs
c) Cosmetic and aesthetic treatments
d) Vaccines for infectious diseases
Answer: c) Cosmetic and aesthetic treatments
13. How does the WHO Essential Medicines List impact health systems in developing
countries? a) It makes health systems more expensive
b) It ensures the availability of vital medicines at affordable prices
c) It limits the number of drugs available for treatment
d) It promotes the use of high-cost specialty drugs
Answer: b) It ensures the availability of vital medicines at affordable prices
14. Which of the following is a reason why certain drugs are included in the WHO Essential
Medicines List? a) High profit margins
b) Cost-effectiveness and proven health benefits
c) Expensive but high demand
d) Sponsored by pharmaceutical companies
Answer: b) Cost-effectiveness and proven health benefits
15. Which of the following is NOT an example of a drug included in the WHO Essential
Medicines List? a) Insulin for diabetes
b) Penicillin for bacterial infections
c) Tamiflu for influenza
d) Hormone replacement therapy
Answer: d) Hormone replacement therapy
16. How are essential medicines selected for inclusion in the Pakistan National List? a) Based on
the recommendations of pharmaceutical companies
b) Based on their availability and need in the country
c) Based on global market trends
d) Based on their use in the military
Answer: b) Based on their availability and need in the country
17. What is a key difference between the WHO Essential Medicines List and the Pakistan
National List? a) The Pakistan National List includes only local brands
b) The Pakistan National List is updated more frequently
c) The Pakistan National List includes additional medicines relevant to the local population
d) There is no difference between the two lists
Answer: c) The Pakistan National List includes additional medicines relevant to the local
population
18. What is the essential feature of the drugs listed on the WHO Essential Medicines List? a)
They must be patented medications
b) They must be effective, safe, and affordable
c) They must be newly developed medications
d) They must only be available in injectable form
Answer: b) They must be effective, safe, and affordable
19. Which of the following medicines is commonly included in both the WHO and Pakistan
Essential Medicines Lists for managing infections? a) Penicillin
b) Prednisone
c) Ibuprofen
d) Metformin
Answer: a) Penicillin
20. Which of the following groups of drugs is most likely to be included in the Essential
Medicines List for treating infectious diseases? a) Antivirals
b) Nonsteroidal anti-inflammatory drugs (NSAIDs)
c) Statins
d) Antidiabetics
Answer: a) Antivirals
Next, I will proceed with the Drug Interactions & Adverse Drug Reactions (ADR) Monitoring. Stay
tuned!
Here are 20 MCQs for Drug Interactions & Adverse Drug Reactions (ADR) Monitoring:
6. Drug Interactions & Adverse Drug Reactions (ADR) Monitoring (20 MCQs)
1. Which of the following best describes a drug interaction? a) A drug causing an allergic
reaction
b) When one drug affects the action of another drug
c) A drug's effect on the liver
d) A drug’s effect on blood pressure
Answer: b) When one drug affects the action of another drug
2. What is an example of a pharmacodynamic drug interaction? a) One drug increases the
absorption of another drug
b) One drug inhibits the metabolism of another drug
c) Two drugs act on the same receptor, leading to an enhanced effect
d) One drug increases the renal clearance of another drug
Answer: c) Two drugs act on the same receptor, leading to an enhanced effect
3. Which of the following is a common mechanism behind drug-drug interactions? a)
Competing for protein binding sites
b) Decreased gastrointestinal motility
c) Increased urine pH
d) Increased albumin synthesis
Answer: a) Competing for protein binding sites
4. What is a major consequence of a drug-drug interaction that leads to an increased risk of
bleeding? a) Enhanced metabolism of anticoagulants
b) Decreased absorption of anticoagulants
c) Inhibition of platelet aggregation
d) Synergistic effect of two anticoagulants
Answer: d) Synergistic effect of two anticoagulants
5. Which of the following is an example of a drug-food interaction? a) Grapefruit juice
inhibiting the metabolism of certain drugs
b) A drug causing a decrease in gastric acid secretion
c) A drug binding to serum proteins
d) A drug affecting kidney function
Answer: a) Grapefruit juice inhibiting the metabolism of certain drugs
6. What is a common adverse drug reaction (ADR) associated with penicillin? a) Rash
b) Nausea
c) Diarrhea
d) Tachycardia
Answer: a) Rash
7. Which of the following is a common adverse reaction of opioid analgesics? a) Drowsiness and
sedation
b) Hypertension
c) Hyperglycemia
d) Excessive thirst
Answer: a) Drowsiness and sedation
8. Which of the following is an example of an idiosyncratic drug reaction? a) Anaphylaxis to
penicillin
b) Nausea from chemotherapy drugs
c) Drowsiness from antihistamines
d) Diarrhea from antibiotics
Answer: a) Anaphylaxis to penicillin
9. What is the most common side effect of NSAIDs (Nonsteroidal Anti-inflammatory Drugs)?
a) Drowsiness
b) GI bleeding or ulcers
c) Weight gain
d) Elevated blood sugar
Answer: b) GI bleeding or ulcers
10. Which of the following drugs is known for causing QT interval prolongation, leading to a
risk of arrhythmias? a) Amiodarone
b) Ibuprofen
c) Paracetamol
d) Metformin
Answer: a) Amiodarone
11. How are drug interactions monitored to prevent ADRs? a) By ignoring all drug interactions
b) Through patient history and regular blood tests
c) By increasing the dosage of the drugs involved
d) By changing the route of drug administration
Answer: b) Through patient history and regular blood tests
12. What is a common side effect of beta-blockers in elderly patients? a) Bradycardia
b) Diarrhea
c) Hyperactivity
d) Insomnia
Answer: a) Bradycardia
13. Which of the following drug classes is most likely to cause drug interactions with
anticoagulants? a) Antibiotics
b) Analgesics
c) Antidepressants
d) Antihistamines
Answer: a) Antibiotics
14. Which drug interaction could potentially result in serotonin syndrome? a) Combining a
selective serotonin reuptake inhibitor (SSRI) with a monoamine oxidase inhibitor (MAOI)
b) Combining aspirin with warfarin
c) Combining metformin with insulin
d) Combining a beta-blocker with an ACE inhibitor
Answer: a) Combining a selective serotonin reuptake inhibitor (SSRI) with a monoamine oxidase
inhibitor (MAOI)
15. Which of the following drugs is known for causing a severe allergic reaction (anaphylaxis)
in some patients? a) Penicillin
b) Paracetamol
c) Omeprazole
d) Metformin
Answer: a) Penicillin
16. What is the most common adverse drug reaction associated with chemotherapy drugs? a)
Hair loss
b) Weight loss
c) Memory impairment
d) Increased appetite
Answer: a) Hair loss
17. Which of the following is an important consideration in ADR monitoring in hospitals? a)
Continuous observation for new symptoms
b) Discontinuing all medications immediately
c) Randomly changing medications
d) Focusing only on drug interactions with non-prescription drugs
Answer: a) Continuous observation for new symptoms
18. What is the role of the pharmacist in drug interaction monitoring? a) Prescribing medication
b) Advising patients on over-the-counter medications
c) Identifying and preventing potential drug interactions
d) Increasing the dosages of drugs for faster results
Answer: c) Identifying and preventing potential drug interactions
19. Which of the following is NOT a common symptom of a drug-induced liver injury (DILI)?
a) Jaundice
b) Nausea and vomiting
c) Elevated liver enzymes
d) Skin rash
Answer: d) Skin rash
20. Which of the following is the primary reason for ADRs being underreported? a) Lack of
patient awareness
b) Underreporting by healthcare professionals due to time constraints
c) Low occurrence rates of ADRs
d) Irrelevant drug safety data
Answer: b) Underreporting by healthcare professionals due to time constraints
Next, I will proceed with the Drug Inspection & Enforcement (10 MCQs). Stay tuned!
Next, I will proceed with the Current Affairs in Pharmaceutical Sector. Stay tuned!
1. Which of the following entities in Pakistan is responsible for regulating the pharmaceutical
sector? a) Pakistan Pharmaceutical Association (PPA)
b) Drug Regulatory Authority of Pakistan (DRAP)
c) Ministry of Finance
d) Pakistan Medical Association (PMA)
Answer: b) Drug Regulatory Authority of Pakistan (DRAP)
2. In 2023, which of the following countries was involved in a major pharmaceutical ban
affecting drug imports to Pakistan? a) India
b) United States
c) China
d) United Kingdom
Answer: a) India
3. Which recent change in Pakistan's drug pricing policy was announced by DRAP? a)
Increase in the price ceiling for essential medicines
b) Introduction of price caps on all generic drugs
c) Removal of price controls for branded medicines
d) Reduction of drug prices across the board
Answer: a) Increase in the price ceiling for essential medicines
4. Which pharmaceutical company in Pakistan received approval from DRAP for producing
the COVID-19 vaccine locally? a) Searle Pakistan
b) Ferozsons Laboratories
c) Pfizer Pakistan
d) Biocon Pakistan
Answer: b) Ferozsons Laboratories
5. Which of the following drugs was recently banned in Pakistan due to safety concerns? a)
Paracetamol
b) Oxycodone
c) Sildenafil
d) Valsartan
Answer: b) Oxycodone
6. The new Drug Regulatory Authority (DRAP) policies aim to enhance: a) Drug accessibility
in rural areas
b) The quality of counterfeit drugs
c) Regulations for drug manufacturing facilities in foreign markets
d) The efficiency of online drug sales in Pakistan
Answer: a) Drug accessibility in rural areas
7. Which of the following pharmaceutical-related policy changes was introduced by DRAP in
2023 to address shortages of life-saving drugs? a) Introduction of a generic drug mandate
b) Reforms in drug importation procedures
c) Ban on non-essential drugs
d) Price freezes for all imported drugs
Answer: b) Reforms in drug importation procedures
8. In 2023, which new international regulatory standard was adopted by DRAP for ensuring
the quality of imported medicines? a) ISO 9001:2015 certification
b) Good Manufacturing Practice (GMP) compliance
c) WHO Good Distribution Practice (GDP)
d) International Council for Harmonisation (ICH) guidelines
Answer: b) Good Manufacturing Practice (GMP) compliance
9. Which pharmaceutical company in Pakistan was involved in a significant recall due to
manufacturing defects in 2023? a) GlaxoSmithKline Pakistan
b) Novartis Pakistan
c) PharmEvo
d) The Searle Company
Answer: d) The Searle Company
10. What initiative has DRAP taken to increase transparency in the pharmaceutical sector in
Pakistan? a) Launching a public-facing drug monitoring system
b) Banning imports of certain medicines
c) Introducing private inspections of pharmacies
d) Reducing the number of registered pharmaceutical companies
Answer: a) Launching a public-facing drug monitoring system
11. Which new drug was recently approved in Pakistan for the treatment of COVID-19? a)
Paxlovid
b) Remdesivir
c) Molnupiravir
d) Favipiravir
Answer: a) Paxlovid
12. What major challenge has the pharmaceutical industry in Pakistan faced recently
according to DRAP? a) Shortage of raw materials
b) Increase in illegal drug exports
c) Rise in counterfeit drug production
d) Surge in drug price inflation
Answer: c) Rise in counterfeit drug production
13. In 2023, which drug was granted emergency approval by DRAP to help combat a new
strain of the flu virus? a) Oseltamivir
b) Dexamethasone
c) Azithromycin
d) Tamiflu
Answer: a) Oseltamivir
14. Which of the following trends has recently impacted the pharmaceutical industry in
Pakistan? a) Declining demand for generic medicines
b) Increasing use of e-prescriptions
c) Emergence of new generic drug manufacturers
d) Rising costs of drug production and importation
Answer: d) Rising costs of drug production and importation
15. Which new law did DRAP introduce to tackle the issue of fake drugs in Pakistan? a) The
Anti-Counterfeit Drug Act
b) The Drug Transparency Act
c) The National Medicines Legislation
d) The Drug Licensing Regulation Act
Answer: a) The Anti-Counterfeit Drug Act
16. What is the recent move by DRAP to improve access to essential medicines in Pakistan’s
rural areas? a) Launching mobile pharmacies
b) Subsidizing drug prices for rural pharmacies
c) Creating a national e-pharmacy platform
d) Importing cheaper drugs from neighboring countries
Answer: a) Launching mobile pharmacies
17. Which country’s pharmaceutical policies are being closely followed by Pakistan to improve
its own drug regulation in 2023? a) United States
b) India
c) China
d) United Kingdom
Answer: b) India
18. What step has Pakistan taken to encourage local pharmaceutical companies to invest in
research and development (R&D)? a) Tax incentives for R&D-related activities
b) Bans on foreign drug imports
c) Increased tariffs on imported medicines
d) Limited access to foreign R&D grants
Answer: a) Tax incentives for R&D-related activities
19. Which international organization has recently increased its collaboration with Pakistan’s
pharmaceutical industry to combat counterfeit drugs? a) World Health Organization (WHO)
b) United Nations (UN)
c) International Criminal Police Organization (Interpol)
d) World Trade Organization (WTO)
Answer: a) World Health Organization (WHO)
20. Which of the following pharmaceuticals in Pakistan received a significant government grant
in 2023 for local vaccine production? a) Ferozsons Laboratories
b) The Searle Company
c) Hira Pharmaceuticals
d) GSK Pakistan
Answer: a) Ferozsons Laboratories
1. Basic Principles of Drug Formulation & Stability Testing (25 MCQs)
1. What is the primary goal of drug formulation? a) To enhance the drug’s taste
b) To ensure the drug is stable and effective
c) To reduce production costs
d) To make the drug aesthetically pleasing
Answer: b) To ensure the drug is stable and effective
2. Which of the following is NOT a common route of drug administration in formulation? a)
Oral
b) Parenteral
c) Transdermal
d) All are common routes
Answer: d) All are common routes
3. What does stability testing of a drug primarily evaluate? a) The price of the drug
b) The safety, quality, and effectiveness of the drug over time
c) The aesthetic appearance of the drug
d) The packaging of the drug
Answer: b) The safety, quality, and effectiveness of the drug over time
4. Which of the following is a factor that can influence the stability of a drug formulation? a)
Temperature
b) Light
c) Humidity
d) All of the above
Answer: d) All of the above
5. In drug formulation, what is the role of a binder? a) To provide color to the tablet
b) To facilitate the binding of the drug components
c) To improve the taste of the drug
d) To enhance the solubility of the drug
Answer: b) To facilitate the binding of the drug components
6. What is the purpose of stability studies in drug formulation? a) To determine how long the
drug will be effective and safe
b) To test the drug’s absorption rate
c) To assess the drug’s taste and odor
d) To evaluate the drug’s packaging
Answer: a) To determine how long the drug will be effective and safe
7. Which of the following is a type of stability testing in drug formulation? a) Accelerated
stability testing
b) Physical stability testing
c) Chemical stability testing
d) All of the above
Answer: d) All of the above
8. Which of the following is a common method used to test the stability of a drug under
different conditions? a) Dissolution testing
b) Accelerated stability testing
c) UV spectrophotometry
d) Liquid chromatography
Answer: b) Accelerated stability testing
9. What is the typical duration for a long-term stability study in drug formulation? a) 3-6
months
b) 6-12 months
c) 12-24 months
d) Over 24 months
Answer: c) 12-24 months
10. Which of the following conditions is NOT typically tested in stability studies? a) Light
b) Temperature
c) Humidity
d) Wind speed
Answer: d) Wind speed
11. Which of the following is the most common method for evaluating the physical stability of a
drug? a) HPLC
b) Microbiological testing
c) Visual inspection for color, texture, and presence of crystals
d) Dissolution testing
Answer: c) Visual inspection for color, texture, and presence of crystals
12. What role does pH play in drug formulation? a) It impacts the solubility and stability of the
drug
b) It controls the taste of the drug
c) It influences the manufacturing cost
d) It determines the color of the drug
Answer: a) It impacts the solubility and stability of the drug
13. What is the purpose of using preservatives in drug formulation? a) To enhance the drug’s
flavor
b) To maintain the drug’s stability and prevent microbial growth
c) To make the drug easier to administer
d) To increase the cost of production
Answer: b) To maintain the drug’s stability and prevent microbial growth
14. Which of the following factors is critical in ensuring the stability of parenteral drug
formulations? a) Sterility
b) pH
c) Packaging
d) All of the above
Answer: d) All of the above
15. The shelf life of a drug formulation is determined primarily by: a) Its taste
b) Its stability over time
c) The drug’s efficacy against a disease
d) The drug’s color and shape
Answer: b) Its stability over time
16. What type of formulation is least likely to undergo stability testing? a) Oral tablet
formulations
b) Injectable formulations
c) Ophthalmic formulations
d) Cosmetics
Answer: d) Cosmetics
17. What is the role of excipients in drug formulation? a) To improve the drug’s therapeutic effect
b) To help in the manufacturing process and enhance stability
c) To reduce the cost of production
d) To determine the drug’s taste
Answer: b) To help in the manufacturing process and enhance stability
18. Which of the following tests is commonly used to evaluate the chemical stability of drugs? a)
Dissolution testing
b) UV spectrophotometry
c) HPLC
d) Both b and c
Answer: d) Both b and c
19. Which of the following is a common cause of instability in drug formulations? a) Exposure to
light
b) Incorrect packaging
c) Incorrect temperature storage
d) All of the above
Answer: d) All of the above
20. What does the term “accelerated stability testing” refer to? a) Testing the drug in real-world
conditions for several years
b) Testing the drug under extreme conditions to predict its shelf life
c) Testing only the chemical stability of the drug
d) Testing the drug’s effects on different diseases
Answer: b) Testing the drug under extreme conditions to predict its shelf life
21. Which of the following is used in stability testing to predict how a drug will behave under
environmental stress? a) Shelf-life prediction models
b) Accelerated aging studies
c) Both a and b
d) Neither a nor b
Answer: c) Both a and b
22. What does the "expiry date" of a drug typically reflect? a) The time at which the drug should
no longer be used
b) The date the drug is manufactured
c) The date the drug is first opened
d) The maximum storage time
Answer: a) The time at which the drug should no longer be used
23. In the context of drug stability, what is the purpose of a "stability-indicating" assay? a) To
detect any change in the drug’s chemical structure or concentration
b) To evaluate the drug’s taste
c) To test the manufacturing process
d) To check for packaging defects
Answer: a) To detect any change in the drug’s chemical structure or concentration
24. Which of the following methods is commonly used to evaluate the physical integrity of drug
tablets over time? a) Hardness testing
b) Disintegration testing
c) Friability testing
d) All of the above
Answer: d) All of the above
25. In formulation development, what does the term “bioavailability” refer to? a) The speed at
which a drug is absorbed into the bloodstream
b) The amount of drug available at the target site
c) The drug’s solubility in the stomach
d) The drug’s stability under various conditions
Answer: b) The amount of drug available at the target site
Here are 25 MCQs for Quality Control Tests for Tablets, Capsules, Syrups, and Injectables:
2. Quality Control Tests for Tablets, Capsules, Syrups, and Injectables (25 MCQs)
I will now proceed with Pharmacopoeial Standards (BP, USP, IP, Pakistan Pharmacopoeia). Stay
tuned!
Here are 25 MCQs for Pharmacopoeial Standards (BP, USP, IP, Pakistan Pharmacopoeia):
Next, I will proceed with Counterfeit & Substandard Drugs Identification. Stay tuned!
Here are 25 MCQs for Counterfeit & Substandard Drugs Identification: