Monographs and pharmacopoeial standards: IP, USP, Ayurvedic, Unani, WHO guidelines MCQs With Answer

Introduction:

The following quiz set focuses on monographs and pharmacopoeial standards relevant to Industrial Pharmacognostical Technology (MPG 104T) for M.Pharm students. It covers national and international standards including the Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), Ayurvedic and Unani pharmacopeias, and WHO guidance on herbal medicines. Emphasis is on monograph structure, identification and assay methods, contaminants, reference standards, and regulatory harmonization. These questions are designed to deepen understanding of how monographs assure quality, safety and consistency of herbal and natural products, and to prepare you for advanced study and practical application in quality control, regulatory affairs and monograph development.

Q1. Which of the following best describes the typical mandatory components of a pharmacopoeial monograph?

• Therapeutic indications, Manufacturer details, Packaging only
• Title, Definition, Identification tests, Assay and Acceptance criteria, Purity tests, Storage conditions
• Price, Marketing authorisation number, Clinical trial data
• Prescription format, Dosage recommendations, Pharmacodynamics

Correct Answer: Title, Definition, Identification tests, Assay and Acceptance criteria, Purity tests, Storage conditions

Q2. Which organization is primarily responsible for publishing the Indian Pharmacopoeia (IP)?

• World Health Organization (WHO)
• United States Pharmacopeial Convention (USP)
• Indian Pharmacopoeia Commission under Ministry of Health and Family Welfare
• Ministry of AYUSH

Correct Answer: Indian Pharmacopoeia Commission under Ministry of Health and Family Welfare

Q3. In herbal monographs, which parameter is most commonly used to ensure batch-to-batch chemical consistency of a botanical raw material?

• Total ash value alone
• Assay of one or more characteristic marker compounds by validated analytical method
• Organoleptic evaluation only
• Moisture content (loss on drying) only

Correct Answer: Assay of one or more characteristic marker compounds by validated analytical method

Q4. WHO guidelines for quality of herbal medicines place primary emphasis on which of the following practices?

• Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP)
• Marketing strategies for herbal products
• Only clinical efficacy trials
• Patent protection for botanicals

Correct Answer: Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP)

Q5. Which statement correctly distinguishes a pharmacopoeial monograph from a general chapter?

• A monograph provides general testing methodology applicable to all substances, while a general chapter describes a single substance
• A monograph contains specific information and acceptance criteria for one substance; a general chapter provides standardized analytical methods or procedural requirements
• Both are identical in scope and interchangeable
• General chapters list therapeutic indications, monographs list prices

Correct Answer: A monograph contains specific information and acceptance criteria for one substance; a general chapter provides standardized analytical methods or procedural requirements

Q6. The primary purpose of an official reference standard in pharmacopeial testing is:

• To replace the need for validated methods
• To provide a certified material for identity, assay calibration and method validation
• To serve as a placebo in clinical trials
• To indicate the therapeutic dose

Correct Answer: To provide a certified material for identity, assay calibration and method validation

Q7. Which authority is responsible for publishing the Ayurvedic Pharmacopoeia of India (API)?

• Indian Pharmacopoeia Commission
• Central Council for Research in Ayurvedic Sciences (CCRAS)
• Ministry of AYUSH / Department of AYUSH, Government of India
• World Health Organization Regional Office for South-East Asia

Correct Answer: Ministry of AYUSH / Department of AYUSH, Government of India

Q8. Which analytical technique is most commonly recommended in modern pharmacopeial monographs for accurate quantification of marker constituents in herbal drugs?

• Thin layer chromatography (TLC) qualitative only
• High performance liquid chromatography (HPLC) or UPLC with validated method
• Organoleptic evaluation
• Simple colorimetric test without validation

Correct Answer: High performance liquid chromatography (HPLC) or UPLC with validated method

Q9. Which international guidance is most directly referenced for stability testing of pharmaceutical substances and finished products?

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• WHO Good Clinical Practice
• USP General Chapter on Microbial Limits
• Ayurvedic Pharmacopoeia general preface

Correct Answer: ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Q10. DNA barcoding in herbal authentication is best described as:

• A substitute for all chemical assays in a monograph
• A complementary botanical identification tool useful for authentication and detection of adulteration/contamination
• An obsolete technique for herbal drugs
• Only useful for microbial testing

Correct Answer: A complementary botanical identification tool useful for authentication and detection of adulteration/contamination

Q11. The Unani Pharmacopoeia of India is published under the oversight of which governmental department?

• Ministry of Electronics and Information Technology
• Department of AYUSH, Government of India
• Indian Council of Medical Research (ICMR)
• Ministry of Defence

Correct Answer: Department of AYUSH, Government of India

Q12. Harmonization of monographs between pharmacopeias (IP, USP, EP) aims primarily to:

• Increase differences to protect local manufacturers
• Reduce duplication, facilitate international trade and provide consistent public health standards
• Replace national regulations entirely
• Prioritise marketing claims over quality testing

Correct Answer: Reduce duplication, facilitate international trade and provide consistent public health standards

Q13. Which group of contaminants is generally addressed by pharmacopeial and WHO guidelines for herbal products?

• Only microbial contaminants
• Heavy metals, pesticide residues, mycotoxins (aflatoxins), and microbial contamination
• Only residual solvents
• Only plasticizers from packaging

Correct Answer: Heavy metals, pesticide residues, mycotoxins (aflatoxins), and microbial contamination

Q14. Which of the following is NOT normally included in a pharmacopoeial monograph?

• Identification tests and acceptance criteria
• Assay procedures and purity limits
• Therapeutic indications and recommended dosing regimens
• Storage and labelling instructions

Correct Answer: Therapeutic indications and recommended dosing regimens

Q15. A complete botanical identification in a herbal monograph should minimally include which information?

• Common local names only
• Full Latin binomial with author citation, family name and specified plant part used
• Colour of flowers only
• Therapeutic use descriptions only

Correct Answer: Full Latin binomial with author citation, family name and specified plant part used

Q16. Which approach is specified in pharmacopeial standards for assessing microbial quality of herbal raw materials and extracts?

• No testing required for botanicals
• Total aerobic microbial count, total yeast and mould count, and absence of specified pathogens as per microbial limits tests
• Only microscope observation for fungi
• Only Gram staining

Correct Answer: Total aerobic microbial count, total yeast and mould count, and absence of specified pathogens as per microbial limits tests

Q17. The WHO Monographs on selected medicinal plants aim to:

• Provide regulatory approval for all herbal products worldwide
• Offer evidence-based monographs summarizing quality control methods, safety and efficacy information to support national monograph development
• Replace national pharmacopeias
• Publish clinical trial protocols only

Correct Answer: Offer evidence-based monographs summarizing quality control methods, safety and efficacy information to support national monograph development

Q18. Which statement correctly reflects a typical feature of a USP monograph?

• A USP monograph contains marketing information and pricing
• A USP monograph contains quality specifications and detailed analytical procedures including acceptance criteria
• A USP monograph is only a suggestion and not enforceable
• A USP monograph lists only traditional uses of the drug without analytical methods

Correct Answer: A USP monograph contains quality specifications and detailed analytical procedures including acceptance criteria

Q19. In herbal monograph development, what is the role of a chemical “marker” compound?

• To serve solely as a flavoring agent
• To act as a measurable constituent used for identity, standardization and quantitative assay
• To replace botanical identification entirely
• To indicate only the geographical origin

Correct Answer: To act as a measurable constituent used for identity, standardization and quantitative assay

Q20. The primary purpose of pharmacopoeial standards in public health is to:

• Protect commercial trademarks
• Ensure the quality, safety and consistency of medicines and medicinal substances used by the public
• Dictate clinical prescribing practices
• Increase the cost of medicines through regulation

Correct Answer: Ensure the quality, safety and consistency of medicines and medicinal substances used by the public

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