Regulations related to formulation development MCQs With Answer

Introduction: Regulations related to formulation development MCQs With Answer provides B. Pharm students with a focused review of regulatory guidelines that govern pharmaceutical formulation development. This introduction covers key keywords such as formulation development, regulatory guidelines, cGMP, ICH (Q1A, Q8, Q9, Q10), stability testing, analytical method validation, dossier (CTD/eCTD), pharmacopoeial standards (USP, IP), quality control, and batch documentation. Understanding these regulations helps ensure product quality, safety, efficacy, and compliance during formulation design, scale-up, and submission. The questions that follow emphasize practical regulatory scenarios, quality systems, and documentation expectations relevant to formulation scientists and regulatory affairs professionals. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which ICH guideline primarily addresses stability testing for new drug substances and products?

• ICH Q1A (Stability)
• ICH Q8 (Pharmaceutical Development)
• ICH Q9 (Quality Risk Management)
• ICH Q10 (Pharmaceutical Quality System)

Correct Answer: ICH Q1A (Stability)

Q2. Which ICH guideline focuses on pharmaceutical development and encourages Quality by Design (QbD)?

• ICH Q1A
• ICH Q8
• ICH Q3A
• ICH Q9

Correct Answer: ICH Q8

Q3. What does GMP stand for in pharmaceutical manufacturing?

• Good Medical Practice
• Good Manufacturing Practice
• Guaranteed Manufacturing Procedure
• General Management Protocol

Correct Answer: Good Manufacturing Practice

Q4. What is the meaning of cGMP commonly used in regulatory contexts?

• central Good Manufacturing Practices
• current Good Manufacturing Practice
• certified Good Manufacturing Proof
• controlled Good Method Protocol

Correct Answer: current Good Manufacturing Practice

Q5. What does CTD stand for when preparing a regulatory dossier?

• Clinical Trial Document
• Common Technical Document
• Certified Testing Dossier
• Controlled Technical Data

Correct Answer: Common Technical Document

Q6. Which authority publishes the “Orange Book” listing approved drug products in the United States?

• European Medicines Agency (EMA)
• World Health Organization (WHO)
• Food and Drug Administration (FDA)
• Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Correct Answer: Food and Drug Administration (FDA)

Q7. What are the ICH accelerated stability testing conditions commonly used for drug products?

• 25°C/60% RH
• 30°C/65% RH
• 40°C/75% RH
• 5°C/60% RH

Correct Answer: 40°C/75% RH

Q8. Which validation parameter ensures an analytical method can accurately measure an analyte in presence of other formulation components?

• Accuracy
• Precision
• Specificity
• Robustness

Correct Answer: Specificity

Q9. Which pharmacopoeial chapter commonly describes microbial limit tests for non-sterile products?

• USP <71> Sterility Tests
• USP <61> Microbiological Examination of Nonsterile Products
• ICH Q1A Stability
• ICH Q3A Impurities

Correct Answer: USP <61> Microbiological Examination of Nonsterile Products

Q10. Which ICH guideline deals specifically with impurities in new drug substances?

• ICH Q3A
• ICH Q3B
• ICH Q7
• ICH Q10

Correct Answer: ICH Q3A

Q11. Which GMP document records the stepwise manufacturing process, materials, and conditions for a batch?

• Master Formula Record / Batch Manufacturing Record
• Stability Protocol
• Clinical Trial Protocol
• Regulatory Submission Cover Letter

Correct Answer: Master Formula Record / Batch Manufacturing Record

Q12. A stability-indicating assay must primarily demonstrate which characteristic?

• High throughput
• Specificity to separate degradation products
• Lowest possible cost
• Compatibility with all excipients

Correct Answer: Specificity to separate degradation products

Q13. Determination of shelf life for a new formulation is based mainly on:

• Cost of packaging
• Accelerated and long-term stability data
• Manufacturer preference
• Excipients listed in pharmacopeia only

Correct Answer: Accelerated and long-term stability data

Q14. Which pharmacopoeia is the official compendium in India?

• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• Indian Pharmacopoeia (IP)
• European Pharmacopoeia (Ph. Eur.)

Correct Answer: Indian Pharmacopoeia (IP)

Q15. What system is required by GMP to manage and document planned changes to manufacturing processes?

• Change control system
• Ad hoc approval
• Informal email approval
• Only regulatory submission update

Correct Answer: Change control system

Q16. Which information is typically mandatory on the primary label of a finished pharmaceutical product?

• Price and distributor profit margin
• Batch number and expiry date
• Manufacturing employee names
• Storage facility GPS coordinates

Correct Answer: Batch number and expiry date

Q17. What term describes the controlled refrigeration logistics required for temperature-sensitive products?

• Warm chain management
• Cold chain management
• Thermal exclusion system
• Ambient logistics control

Correct Answer: Cold chain management

Q18. Which ICH guideline provides principles for Quality Risk Management?

• ICH Q5
• ICH Q7
• ICH Q9
• ICH Q11

Correct Answer: ICH Q9

Q19. Which ICH guideline outlines a model for a pharmaceutical quality system throughout product lifecycle?

• ICH Q5C
• ICH Q10
• ICH M4
• ICH Q3C

Correct Answer: ICH Q10

Q20. What does eCTD mean in regulatory submissions?

• electronic Clinical Trial Data
• electronic Common Technical Document
• enhanced Compliance Technical Dossier
• electronic Certified Test Documents

Correct Answer: electronic Common Technical Document

Q21. The primary objective of bioequivalence studies for generics is to demonstrate:

• Identical impurity profiles
• Equivalence in rate and extent of absorption
• Equal cost of manufacturing
• Similarity in packaging design

Correct Answer: Equivalence in rate and extent of absorption

Q22. In analytical method validation, “accuracy” refers to:

• Repeatability under the same conditions
• Closeness of measured value to the true value
• Ability to separate analyte from impurities
• Resistance to small deliberate changes

Correct Answer: Closeness of measured value to the true value

Q23. For many climatic zones, an ICH intermediate stability condition is commonly set at which temperature and RH?

• 25°C/40% RH
• 30°C/65% RH
• 40°C/75% RH
• 5°C/30% RH

Correct Answer: 30°C/65% RH

Q24. Good documentation practice requires which action when correcting an entry in a batch record?

• Erase the mistake and rewrite
• Use white-out to hide the error
• Strike through with a single line, initial, date and explain
• Ignore small errors in paperwork

Correct Answer: Strike through with a single line, initial, date and explain

Q25. Regulatory expectations for pharmaceutical excipients typically require which of the following?

• Excipient supplier can be anonymous
• Excipient must meet applicable pharmacopeial monograph or suitable specifications
• Excipient testing is never required
• Only color of excipient is regulated

Correct Answer: Excipient must meet applicable pharmacopeial monograph or suitable specifications

Q26. Dissolution specifications for an oral solid dosage form are normally defined in:

• Product specification and pharmacopeial monograph
• Packaging artwork only
• Employee training manual
• Sales brochure

Correct Answer: Product specification and pharmacopeial monograph

Q27. Which of the following is NOT a standard analytical method validation parameter?

• Accuracy
• Precision
• Robustness
• Packaging design

Correct Answer: Packaging design

Q28. What does PQR stand for, a periodic regulatory requirement in GMP?

• Product Quality Review
• Periodic Qualification Report
• Process Quality Reassessment
• Production Quick Review

Correct Answer: Product Quality Review

Q29. After marketing authorization, the primary regulatory activity to ensure ongoing safety is:

• Pre-clinical toxicology only
• Pharmacovigilance and adverse event reporting
• Batch compression speed increase
• Only annual financial audit

Correct Answer: Pharmacovigilance and adverse event reporting

Q30. Which agency is the central regulatory authority for medicines in the European Union?

• FDA
• MHRA
• EMA
• DCGI

Correct Answer: EMA

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