EC GMP principles Directive 91/356/EEC MCQs With Answer

Introduction

EC GMP principles Directive 91/356/EEC MCQs With Answer provides M.Pharm students with a focused review of the European Community Good Manufacturing Practice (GMP) framework as set out in Directive 91/356/EEC. This directive establishes fundamental principles and guidelines to ensure pharmaceutical quality, covering responsibilities of manufacturing authorisation holders, Qualified Persons, documentation, premises, production, quality control, distribution, and self-inspection. The following set of multiple-choice questions is designed to deepen understanding of regulatory expectations, practical implementation of GMP, and the roles required to maintain product safety and efficacy. Answers are provided to help students evaluate knowledge and prepare for regulatory and exam scenarios.

Q1. What is the primary objective of Directive 91/356/EEC on GMP?

• To harmonize patent laws across EU states
• To establish pricing guidelines for medicinal products
• To set principles and guidelines to ensure the quality of medicinal products for human use
• To regulate marketing and advertising of medicines

Correct Answer: To set principles and guidelines to ensure the quality of medicinal products for human use

Q2. Who holds ultimate legal responsibility for ensuring that each batch of a medicinal product has been manufactured and tested in accordance with Directive 91/356/EEC before release?

• The Qualified Person (QP)
• The Pharmacovigilance Officer
• The Marketing Authorisation Holder (MAH)
• The Clinical Trial Sponsor

Correct Answer: The Qualified Person (QP)

Q3. Directive 91/356/EEC requires that Good Manufacturing Practice covers which stages?

• Only final product testing
• Research and discovery only
• All stages of production, control and distribution that can affect product quality
• Marketing and sales activities

Correct Answer: All stages of production, control and distribution that can affect product quality

Q4. According to the principles of Directive 91/356/EEC, which document should specify the detailed procedures, instructions and records needed to ensure reproducible manufacturing?

• Marketing plan
• Master production formula and batch production records
• Sales forecast report
• Employee handbook

Correct Answer: Master production formula and batch production records

Q5. What is the intended role of self-inspection (quality audits) as described in the Directive?

• To replace regulatory inspections entirely
• To provide an internal monitoring tool to detect non-conformances and ensure continuous improvement
• To be performed only before product launch
• To manage marketing strategies

Correct Answer: To provide an internal monitoring tool to detect non-conformances and ensure continuous improvement

Q6. Which of the following best describes the relationship between Quality Assurance (QA) and Quality Control (QC) under Directive 91/356/EEC?

• QA focuses on documentation; QC focuses on sales
• QA is responsible for the overall quality system, while QC handles sampling, testing and release testing
• QA and QC are identical and interchangeable terms
• QC sets GMP policy; QA performs product testing

Correct Answer: QA is responsible for the overall quality system, while QC handles sampling, testing and release testing

Q7. When manufacturing is contracted out, who remains responsible for GMP compliance according to the Directive?

• The contract acceptor only
• The contract giver (MAH) retains responsibility for GMP compliance
• The national inspectorate only
• The logistics provider

Correct Answer: The contract giver (MAH) retains responsibility for GMP compliance

Q8. Directive 91/356/EEC emphasizes validation. What is the main purpose of validation in GMP?

• To provide marketing claims for the product
• To ensure that processes consistently produce results meeting predetermined specifications
• To lower production costs
• To document employee performance reviews

Correct Answer: To ensure that processes consistently produce results meeting predetermined specifications

Q9. Which personnel-related requirement is specifically highlighted by the Directive for GMP compliance?

• All staff must have a PhD
• Personnel must be trained, qualified and have clearly assigned responsibilities
• Personnel are only required for production lines, not QC
• Contractors may be used without oversight

Correct Answer: Personnel must be trained, qualified and have clearly assigned responsibilities

Q10. According to Directive 91/356/EEC, what is the purpose of maintaining comprehensive documentation and records?

• To satisfy marketing departments
• To enable traceability, reproducibility and evidence that GMP has been followed
• To prevent employees from leaving the company
• To reduce production speed

Correct Answer: To enable traceability, reproducibility and evidence that GMP has been followed

Q11. How does the Directive recommend handling deviations from approved procedures?

• Ignore minor deviations to save time
• Document deviations, investigate root cause, implement corrective/preventive actions (CAPA)
• Destroy all implicated batches without investigation
• Assign blame to a single operator publicly

Correct Answer: Document deviations, investigate root cause, implement corrective/preventive actions (CAPA)

Q12. What is the Directive’s stance on the independence of Quality Control laboratories?

• QC must be subordinate to production to speed up release
• QC should be functionally independent of production to ensure objective testing
• QC can be outsourced to sales teams
• QC is optional for well-known products

Correct Answer: QC should be functionally independent of production to ensure objective testing

Q13. Which of the following is a key requirement for premises and equipment under Directive 91/356/EEC?

• They should be aesthetically pleasing for visitors
• They must be designed, constructed and maintained to suit the operations and to minimize contamination and cross-contamination
• They can be repurposed from any industrial facility without modification
• They only need to be cleaned annually

Correct Answer: They must be designed, constructed and maintained to suit the operations and to minimize contamination and cross-contamination

Q14. What does the Directive say about storage and distribution of medicinal products?

• Products should be stored and distributed in conditions that maintain their quality and traceability
• Storage conditions are irrelevant once the product is released
• Distribution may ignore temperature control for short distances
• Only retail pharmacies are responsible for storage conditions

Correct Answer: Products should be stored and distributed in conditions that maintain their quality and traceability

Q15. Which document must a Qualified Person review before certifying batch release under the Directive?

• Only the marketing brochure
• Production and QC records, including batch documentation and certificates of analysis
• Employee attendance logs
• Patent applications

Correct Answer: Production and QC records, including batch documentation and certificates of analysis

Q16. How are complaints and recalls addressed in the Directive?

• Complaints may be filed without investigation
• Manufacturers must have procedures to investigate complaints and to recall products if necessary
• Recalls are the responsibility of wholesalers only
• Complaints should be forwarded to marketing agencies

Correct Answer: Manufacturers must have procedures to investigate complaints and to recall products if necessary

Q17. In the context of the Directive, what is the significance of change control?

• It is used to approve new sales channels
• It ensures that changes to processes, equipment, materials or documents are evaluated and authorised before implementation
• It restricts innovation in manufacturing
• It applies only to packaging design changes

Correct Answer: It ensures that changes to processes, equipment, materials or documents are evaluated and authorised before implementation

Q18. Directive 91/356/EEC applies to investigational medicinal products (IMPs). What implication does this have?

• IMPs are exempt from quality requirements
• GMP principles must be applied to IMP manufacture to ensure patient safety and data integrity in clinical trials
• Only marketing authorisation products need GMP
• Clinical investigators are responsible for GMP compliance

Correct Answer: GMP principles must be applied to IMP manufacture to ensure patient safety and data integrity in clinical trials

Q19. What is the role of documentation of analytical methods and specifications under the Directive?

• Analytical methods should be secret and undocumented
• Methods and specifications must be validated, documented and used to ensure product compliance
• Only visual inspection methods are acceptable
• Specifications can be changed without record

Correct Answer: Methods and specifications must be validated, documented and used to ensure product compliance

Q20. How should companies prepare for regulatory GMP inspections according to Directive 91/356/EEC principles?

• Avoid inspections by hiding records
• Maintain up-to-date records, implement self-inspections and corrective actions, and ensure staff are prepared to demonstrate GMP compliance
• Only prepare if an inspection is scheduled within 24 hours
• Delegate all preparation to external marketing consultants

Correct Answer: Maintain up-to-date records, implement self-inspections and corrective actions, and ensure staff are prepared to demonstrate GMP compliance

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