Manufacture of drugs for test, examination and analysis MCQs With Answer

Introduction

Manufacture of drugs for test, examination and analysis is a focused area in pharmaceutical production where small-scale, controlled batches, reference standards and analytical samples are prepared for quality control and research. B.Pharm students should understand concepts like analytical standards, sample preparation, assay development, impurity profiling, stability testing, sterility assurance, calibration, validation parameters, and regulatory compliance (GMP/GLP). This topic links pharmaceutical analysis with manufacturing practice, emphasizing documentation, traceability, and safe handling of reagents and controls. Mastery helps in accurate assay results, reliable Certificates of Analysis, and sound decision-making during drug development and routine quality control. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is a primary reference standard in pharmaceutical analysis?

• A material with unknown purity used as a control
• A highly characterized substance of known purity used for calibration
• An in-house sample used only for method development
• A placebo used in dissolution testing

Correct Answer: A highly characterized substance of known purity used for calibration

Q2. Which document typically accompanies an analytical reference standard and states its properties?

• Batch manufacturing record
• Certificate of Analysis (CoA)
• Material Safety Data Sheet (MSDS)
• Marketing authorization

Correct Answer: Certificate of Analysis (CoA)

Q3. In manufacture of drugs for analysis, the term “stability-indicating method” refers to:

• A method that measures only impurities
• A method that can specifically detect the active drug without interference from degradation products
• An unspecific assay used for routine checks
• A microbiological test for sterility

Correct Answer: A method that can specifically detect the active drug without interference from degradation products

Q4. Which parameter assesses the closeness of repeated measurements under unchanged conditions?

• Accuracy
• Specificity
• Precision
• Robustness

Correct Answer: Precision

Q5. Which analytical technique is most commonly used for impurity profiling of small molecule drugs?

• Thermogravimetric analysis (TGA)
• High-performance liquid chromatography (HPLC)
• Polarimetry
• Microscopy

Correct Answer: High-performance liquid chromatography (HPLC)

Q6. For water content determination in hygroscopic drug samples, which method is preferred?

• Karl Fischer titration
• UV-visible spectroscopy
• pH titration
• Gas chromatography with flame ionization detector

Correct Answer: Karl Fischer titration

Q7. What is the main purpose of forced degradation studies when preparing analytical samples?

• To accelerate manufacturing speed
• To identify degradation pathways and develop stability-indicating assays
• To sterilize the sample before assay
• To reduce impurity levels in the sample

Correct Answer: To identify degradation pathways and develop stability-indicating assays

Q8. Which practice is essential to prevent cross-contamination in small-scale manufacture for analysis?

• Using shared utensils without cleaning
• Segregation of workflows and dedicated equipment
• Mixing batches from different products
• Storing all reagents together on open benches

Correct Answer: Segregation of workflows and dedicated equipment

Q9. In analytical method validation, LOD stands for:

• Limit of Determination
• Level of Detection
• Limit of Detection
• Limit of Decision

Correct Answer: Limit of Detection

Q10. Which of the following is a critical control for sterility testing sample preparation?

• Using non-sterile water for dissolution media
• Performing manipulations in a validated aseptic area
• Allowing open handling on a bench
• Using expired culture media

Correct Answer: Performing manipulations in a validated aseptic area

Q11. What does assay potency measure in analytical manufacture samples?

• The dissolution rate only
• The amount of active pharmaceutical ingredient present
• The color of the formulation
• The microbiological load

Correct Answer: The amount of active pharmaceutical ingredient present

Q12. Which validation characteristic evaluates method’s ability to measure the analyte in presence of other components?

• Precision
• Specificity/selectivity
• Repeatability
• Linearity

Correct Answer: Specificity/selectivity

Q13. A secondary reference standard is typically:

• Used without traceability
• Calibrated against a primary reference standard
• Less pure and therefore unusable
• Only used for microbiological assays

Correct Answer: Calibrated against a primary reference standard

Q14. Which container-closure attribute is most important for stability samples sensitive to moisture?

• Transparency
• Moisture barrier properties
• Branding labels
• Color of the cap

Correct Answer: Moisture barrier properties

Q15. In preparing standard solutions for HPLC calibration, why is volumetric glassware preferred?

• Because it is cheaper
• For accurate and precise volume measurement
• It increases sample degradation
• It reacts with solvents improving peak shape

Correct Answer: For accurate and precise volume measurement

Q16. Which regulatory guideline primarily governs good practices for small-scale manufacture used in analysis?

• ICH Q12
• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Pharmacovigilance guideline

Correct Answer: Good Manufacturing Practice (GMP)

Q17. What is the main benefit of using a placebo or blank during analytical testing?

• To increase assay signal
• To assess matrix interference and baseline response
• To replace the active ingredient permanently
• To sterilize samples

Correct Answer: To assess matrix interference and baseline response

Q18. Which metric describes variability relative to the mean and is often used in analytical precision?

• Standard deviation (SD)
• Relative standard deviation (RSD)
• Mean absolute deviation (MAD)
• Coefficient of determination (R²)

Correct Answer: Relative standard deviation (RSD)

Q19. During manufacture of test drugs, what is the purpose of a batch manufacturing record?

• To detail promotional strategies
• To document manufacturing steps, materials and personnel for traceability
• To certify product for sale
• To list only raw material suppliers

Correct Answer: To document manufacturing steps, materials and personnel for traceability

Q20. Which test is specifically used to detect bacterial endotoxins in parenteral test samples?

• Sterility test
• Limulus Amebocyte Lysate (LAL) assay
• Gram staining
• pH measurement

Correct Answer: Limulus Amebocyte Lysate (LAL) assay

Q21. What is the purpose of placebo formulation in analytical dissolution testing?

• To accelerate the drug release
• To evaluate the influence of excipients on dissolution behavior
• To increase assay sensitivity
• To serve as a sterility indicator

Correct Answer: To evaluate the influence of excipients on dissolution behavior

Q22. Which stability condition is commonly used for accelerated stability testing according to ICH guidelines?

• 5°C ± 3°C, 60% RH
• 25°C ± 2°C, 60% RH
• 40°C ± 2°C, 75% RH
• 50°C ± 5°C, 90% RH

Correct Answer: 40°C ± 2°C, 75% RH

Q23. Which of the following is a critical quality attribute for analytical reference materials?

• Unknown impurity profile
• Validated identity, purity, and stability
• No documentation of origin
• Variable potency between vials

Correct Answer: Validated identity, purity, and stability

Q24. What is the best practice for labeling analytical samples and standards?

• Use permanent identifiers with batch number, concentration, and expiry
• Label only by analyst initials
• Use generic names without dates
• Leave labels blank to reduce clutter

Correct Answer: Use permanent identifiers with batch number, concentration, and expiry

Q25. During assay validation, which test evaluates if small deliberate changes to method parameters affect results?

• Linearity
• Robustness
• Accuracy
• Specificity

Correct Answer: Robustness

Q26. Why is documentation and traceability crucial in manufacture for analytical use?

• It reduces the need for testing
• It ensures reproducibility, regulatory compliance and investigation capability
• It allows skipping validation
• It is only useful for marketing

Correct Answer: It ensures reproducibility, regulatory compliance and investigation capability

Q27. Which practice minimizes analytical errors during sample preparation?

• Using uncalibrated pipettes routinely
• Following standardized SOPs and using calibrated instruments
• Skipping filtration of solutions
• Mixing samples from different studies

Correct Answer: Following standardized SOPs and using calibrated instruments

Q28. What is a limit test in pharmacopeial analysis?

• A quantitative assay for potency
• A qualitative or semi-quantitative test to ensure impurity is below a specified limit
• An instruction to discard the sample
• A test for packaging integrity

Correct Answer: A qualitative or semi-quantitative test to ensure impurity is below a specified limit

Q29. Which sample handling practice is critical for photolabile drugs used in analysis?

• Expose to bright light to check stability
• Protect from light using amber containers and minimal exposure
• Store under direct sunlight to speed testing
• Leave open on the bench overnight

Correct Answer: Protect from light using amber containers and minimal exposure

Q30. What is the significance of system suitability tests before running analytical batches?

• They are optional and rarely used
• They confirm instrument performance, chromatographic resolution and reproducibility
• They replace sample analysis
• They are used only in microbiology labs

Correct Answer: They confirm instrument performance, chromatographic resolution and reproducibility

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com