Documentation and regulatory dossier preparation for export registration MCQs With Answer

Introduction

This quiz set on Documentation and Regulatory Dossier Preparation for Export Registration is designed specifically for M.Pharm (Industrial Pharmacognostical Technology) students. It focuses on practical and regulatory knowledge required to prepare robust dossiers for export of herbal and botanical products. Questions cover dossier structure (CTD/eCTD), module-specific requirements, phytochemical standardization, stability data, GMP and quality certificates, analytical validation, impurity controls, labeling, and international regulatory expectations. The intent is to reinforce detailed concepts used in industry and regulatory submissions, helping students identify documentation gaps, understand global compliance standards, and prepare confidently for real-world export registration and inspection scenarios.

Q1. What is the standard dossier format most commonly accepted by major regulatory authorities for new drug and herbal product submissions?

• Common Technical Document (CTD)
• Manufacturer Technical File (MTF)
• Product Information Brochure (PIB)
• Export Certification Pack (ECP)

Correct Answer: Common Technical Document (CTD)

Q2. Which CTD module contains administrative and prescribing information specific to the region of submission (e.g., application forms, labeling, and certificates)?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 1

Q3. For herbal raw materials, which documentation is essential to unequivocally establish botanical identity?

• Voucher specimen, macroscopic and microscopic descriptions, and DNA barcode
• Only supplier declaration of authenticity
• Only HPLC chromatogram
• Only photograph of the plant

Correct Answer: Voucher specimen, macroscopic and microscopic descriptions, and DNA barcode

Q4. Which guideline is primary for stability testing of pharmaceuticals and used by regulators worldwide to define storage conditions and shelf-life extrapolation?

• ICH Q1A (R2)
• ICH Q2 (R1)
• ICH Q7
• WHO TRS 961

Correct Answer: ICH Q1A (R2)

Q5. In an export dossier for a botanical extract, which document describes manufacturing process, control of critical steps, and equipment used?

• Manufacturing Process Description and Batch Manufacturing Record (BMR)
• Certificate of Analysis (COA)
• Pharmacovigilance Plan
• Marketing Authorization Letter

Correct Answer: Manufacturing Process Description and Batch Manufacturing Record (BMR)

Q6. Which certificate demonstrates that a pharmaceutical product is authorized for sale in the exporting country and is often required by importing authorities?

• Certificate of Pharmaceutical Product (CPP)
• Certificate of Analysis (COA)
• Certificate of Origin (COO)
• Good Manufacturing Practice (GMP) Certificate

Correct Answer: Certificate of Pharmaceutical Product (CPP)

Q7. For botanical products, which of the following impurity limits are typically required and must be included in the dossier?

• Heavy metals, pesticide residues, microbial limits, and mycotoxins
• Only heavy metals
• Only solvent residues
• Only residual actives

Correct Answer: Heavy metals, pesticide residues, microbial limits, and mycotoxins

Q8. Which module of the CTD contains the quality information including drug substance and drug product specifications, analytical methods, and stability data?

• Module 3
• Module 2
• Module 4
• Module 1

Correct Answer: Module 3

Q9. For analytical methods included in a dossier, which ICH guideline is most relevant for validation expectations (accuracy, precision, specificity, etc.)?

• ICH Q2 (R1)
• ICH Q7
• ICH Q1A
• ICH M4

Correct Answer: ICH Q2 (R1)

Q10. What is the role of a Certificate of Analysis (COA) in an export dossier?

• Provides batch-specific analytical test results and evidence of compliance with specifications
• Serves as the marketing authorization
• Replaces the need for stability data
• Is only a shipping document with no analytical value

Correct Answer: Provides batch-specific analytical test results and evidence of compliance with specifications

Q11. Which documentation element is critical to justify the choice of marker compounds used for standardization of a herbal extract?

• Scientific rationale including pharmacological relevance and analytical suitability
• Only the availability of commercial standards
• Only chromatographic peak height
• Only manufacturer preference

Correct Answer: Scientific rationale including pharmacological relevance and analytical suitability

Q12. Which international guideline covers Good Manufacturing Practices relevant to the manufacture of active pharmaceutical ingredients and is often referenced in dossiers?

• ICH Q7
• ICH Q3
• ICH E6
• ICH M10

Correct Answer: ICH Q7

Q13. When preparing stability data for an export dossier to a tropical country (Zone IVB), what is the appropriate climatic condition for long-term studies?

• 25°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 65% RH ± 5% RH
• 40°C ± 2°C / 75% RH ± 5% RH
• 2–8°C storage only

Correct Answer: 30°C ± 2°C / 65% RH ± 5% RH

Q14. For eCTD submissions, which of the following is true regarding Module 3 technical documents?

• They must be placed in the specific eCTD lifecycle folders and formatted per regional guidance
• They can be submitted as a single unstructured PDF
• Module 3 is optional for herbal exports
• Only clinical data are required in Module 3

Correct Answer: They must be placed in the specific eCTD lifecycle folders and formatted per regional guidance

Q15. What is the primary purpose of providing a Stability-Indicating Method in the dossier?

• To accurately quantify active markers and separate degradation products under stress conditions
• To speed up routine QC testing regardless of specificity
• To replace the need for forced degradation studies
• To be used only for marketing purposes

Correct Answer: To accurately quantify active markers and separate degradation products under stress conditions

Q16. Which document demonstrates that a manufacturing site complies with Good Manufacturing Practices and is usually issued by the competent authority?

• GMP Certificate
• Certificate of Analysis
• Free Sale Certificate
• Certificate of Origin

Correct Answer: GMP Certificate

Q17. For herbal product dossiers, why is a comprehensive drug safety/poison information and pharmacovigilance section important?

• Because regulators require ongoing safety monitoring and a plan for adverse event reporting in the importing country
• Because it can replace the need for clinical data entirely
• Because safety is not relevant for traditional medicines
• Because it only affects labeling color

Correct Answer: Because regulators require ongoing safety monitoring and a plan for adverse event reporting in the importing country

Q18. What is usually required in the dossier to prove the consistency of an herbal extract from batch to batch?

• Comparative chromatographic fingerprints and specification data from multiple batches
• Only a single batch certificate
• Only supplier marketing brochures
• Only organoleptic descriptions

Correct Answer: Comparative chromatographic fingerprints and specification data from multiple batches

Q19. Which part of the export dossier addresses container closure system suitability, extractables & leachables, and compatibility with the product?

• Packaging and Container Closure Documentation in Module 3
• Module 5 Clinical Study Reports
• Module 1 Administrative Documents only
• Module 4 Nonclinical Study Reports

Correct Answer: Packaging and Container Closure Documentation in Module 3

Q20. When exporting a herbal product to the EU, which local regulatory category might apply if the product is intended as more than a simple traditional remedy and supported by clinical data?

• Herbal Medicinal Product (well-established use or traditional use or fully licensed medicinal product)
• Food Supplement only
• COSMETIC product exclusively
• Novel Food by default

Correct Answer: Herbal Medicinal Product (well-established use or traditional use or fully licensed medicinal product)

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