Bulk Active Chemical Post Approval Changes (BACPAC) MCQs With Answer

Bulk Active Chemical Post Approval Changes (BACPAC) MCQs With Answer

This quiz collection is designed for M.Pharm students studying Product Development and Technology Transfer. It focuses on Bulk Active Chemical Post Approval Changes (BACPAC) — regulatory and technical aspects that govern modifications to active pharmaceutical ingredient (API) manufacturing after approval. The questions cover definitions, regulatory frameworks, documentation (DMF/ASMF/CEP), risk assessment, comparability, analytical and stability requirements, and practical examples of changes such as scale-up, polymorph changes, and site transfers. These MCQs aim to deepen understanding of how to evaluate, justify and document API changes to ensure continued quality, safety and supply of medicinal products.

Q1. What best defines a Bulk Active Chemical Post Approval Change (BACPAC)?

• A planned change to drug product packaging after marketing
• A post-approval modification to the manufacturing, control or supply of a bulk active pharmaceutical ingredient that may affect quality, safety or supply
• An initial registration dossier for a new active substance
• A clinical protocol amendment for a trial involving an API

Correct Answer: A post-approval modification to the manufacturing, control or supply of a bulk active pharmaceutical ingredient that may affect quality, safety or supply

Q2. What is the primary objective of regulatory BACPAC guidance?

• To reduce costs of API production by removing controls
• To ensure continued quality, safety and uninterrupted supply following post-approval changes
• To standardize excipient selection across products
• To replace GMP requirements with self-assessments

Correct Answer: To ensure continued quality, safety and uninterrupted supply following post-approval changes

Q3. Which ICH guideline specifically provides tools for post-approval change management and lifecycle approaches?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q12

Correct Answer: ICH Q12

Q4. Which classification scheme is commonly used in the EU for regulatory variations including BACPAC?

• SUPAC categories I–IV
• Type IA, Type IB and Type II variations
• Phase I, Phase II, Phase III changes
• Category A, B, and C marketing changes

Correct Answer: Type IA, Type IB and Type II variations

Q5. Which type of post-approval change generally requires prior regulatory approval before implementation?

• Major changes that can impact critical quality attributes and patient safety
• Minor administrative label text edits
• Cosmetic packaging artwork refreshes
• Routine in-process sampling adjustments

Correct Answer: Major changes that can impact critical quality attributes and patient safety

Q6. When an API synthetic route is changed, which regulatory dossier should typically be updated?

• Clinical trial protocols
• Drug Master File (DMF) or Active Substance Master File (ASMF)
• Marketing authorisation for the finished product only, never the API file
• Only the local price dossier

Correct Answer: Drug Master File (DMF) or Active Substance Master File (ASMF)

Q7. What is the purpose of a comparability study after a significant API change?

• To compare regulatory fees between countries
• To demonstrate that pre-change and post-change material are comparable in relevant quality attributes
• To identify new marketing opportunities
• To validate new batch recording templates

Correct Answer: To demonstrate that pre-change and post-change material are comparable in relevant quality attributes

Q8. Which analytical techniques are essential for characterizing a change in API polymorphic form?

• X-ray powder diffraction (XRPD)
• Differential scanning calorimetry (DSC)
• Fourier-transform infrared spectroscopy (FTIR)
• All of the above techniques

Correct Answer: All of the above techniques

Q9. According to ICH Q3C principles, how should Class I residual solvents be treated in API manufacturing?

• They are preferred solvents for cost reasons
• They should be avoided or substituted where possible due to toxicity
• They are exempt from limits
• They are only used in finished product coatings

Correct Answer: They should be avoided or substituted where possible due to toxicity

Q10. When scaling up API batch size, the most critical aspect to evaluate is:

• The impact on impurity profile and other critical quality attributes
• The color of the factory floor
• The font size on labels
• The length of employee breaks

Correct Answer: The impact on impurity profile and other critical quality attributes

Q11. What role does Quality Risk Management (QRM) play in assessing BACPACs?

• QRM is only used for clinical safety monitoring
• QRM helps identify, evaluate and control risks associated with post-approval changes
• QRM replaces all analytical testing requirements
• QRM is optional and not recommended

Correct Answer: QRM helps identify, evaluate and control risks associated with post-approval changes

Q12. What does PACMP stand for in the context of ICH Q12?

• Pharmaceutical Active Compound Manufacturing Plan
• Post-Approval Change Management Protocol
• Pre-approval Analytical Change Management Proposal
• Product Authorization and Compliance Monitoring Program

Correct Answer: Post-Approval Change Management Protocol

Q13. For a change of API manufacturing site, regulators usually expect which of the following?

• Full comparability data including validation batches and updated GMP information
• No documentation if the API name is unchanged
• Only a telephone call to the regulator
• Immediate centralised revocation of the marketing authorisation

Correct Answer: Full comparability data including validation batches and updated GMP information

Q14. When replacing an analytical method used for API release testing, what must be demonstrated?

• Equivalence between the old and new methods and proper validation of the new method
• Only the new method’s precision at one concentration
• No testing if the lab is ISO certified
• Only the new method’s system suitability once

Correct Answer: Equivalence between the old and new methods and proper validation of the new method

Q15. What is a CEP in the context of API regulatory files?

• Certificate of Equivalence for packaging materials
• Certificate of Suitability issued by EDQM confirming compliance with the relevant monograph
• Clinical Endpoint Protocol for bioequivalence
• Centralised Export Permit for APIs

Correct Answer: Certificate of Suitability issued by EDQM confirming compliance with the relevant monograph

Q16. Which ICH guideline addresses impurities in new drug substances (including qualification thresholds)?

• ICH Q1A
• ICH Q3A
• ICH Q6A
• ICH Q11

Correct Answer: ICH Q3A

Q17. Which of the following is NOT typically considered a BACPAC example for an API?

• Change in API synthetic route
• Change in tablet coating color
• Change in crystallization solvent for the API
• Change of starting material supplier for the API synthesis

Correct Answer: Change in tablet coating color

Q18. If a significant change is made to the API that could affect stability, regulators will most likely require:

• New stability studies under appropriate ICH conditions to support shelf life
• No stability data if the assay remains the same
• Only a 1-day forced degradation test
• Only a statement from the manufacturer without data

Correct Answer: New stability studies under appropriate ICH conditions to support shelf life

Q19. How are GMP certificates and inspections related to BACPAC when changing an API site?

• Regulators may require current GMP compliance evidence and may request inspections of the new site
• GMP certificates are irrelevant for API changes
• Only product pricing documents are required
• GMP is only needed for finished products, not APIs

Correct Answer: Regulators may require current GMP compliance evidence and may request inspections of the new site

Q20. If an API change leads to a new or increased impurity that is above qualification thresholds, what additional evaluation is typically necessary?

• Toxicological qualification or safety assessment of the impurity
• A change of company logo
• Reduction of tablet size for the product
• Only an update to manufacturing floor maps

Correct Answer: Toxicological qualification or safety assessment of the impurity

Download