Pharmaceutical Inspection Convention (PIC) guidelines MCQs With Answer

Pharmaceutical Inspection Convention (PIC) guidelines MCQs With Answer is designed to help M.Pharm students deepen their understanding of international GMP cooperation and inspection practices. This collection focuses on the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and its guidelines, inspector roles, GMP Guide structure, annexes, mutual reliance, training, and inspection reporting. These MCQs go beyond basic definitions to test application, regulatory implications, and inspectorate interactions with industry. Each question is followed by four clear options and the correct answer to aid revision and self-assessment. Use these questions to prepare for university exams, viva voce, or interviews related to Quality Control & Quality Assurance in pharmaceutical regulation.

Q1. What is the primary objective of the Pharmaceutical Inspection Convention/Scheme (PIC/S)?

• To issue GMP licences to pharmaceutical manufacturers
• To harmonize Good Manufacturing Practice (GMP) standards and promote cooperation among national inspection authorities
• To replace national regulatory authorities with a single international regulator
• To standardize pharmaceutical pricing across member countries

Correct Answer: To harmonize Good Manufacturing Practice (GMP) standards and promote cooperation among national inspection authorities

Q2. Which statement best describes the legal status of PIC/S?

• PIC/S is a binding international treaty with enforcement powers
• PIC/S is an informal, non-binding cooperative scheme for GMP inspectorates
• PIC/S is a commercial accreditation body for contract manufacturers
• PIC/S is a United Nations agency overseeing drug approvals

Correct Answer: PIC/S is an informal, non-binding cooperative scheme for GMP inspectorates

Q3. Which document is the central reference for GMP under PIC/S?

• PIC/S Pharmacopoeia
• PIC/S GMP Guide (based on EU GMP)
• WHO International Nomenclature of Medicines
• OECD Good Practice Guide

Correct Answer: PIC/S GMP Guide (based on EU GMP)

Q4. Which PIC/S annex specifically addresses the manufacture of sterile medicinal products?

• Annex 2
• Annex 11
• Annex 1
• Annex 5

Correct Answer: Annex 1

Q5. Does PIC/S itself issue GMP certificates to pharmaceutical manufacturers?

• Yes, PIC/S issues global GMP certificates recognised by all members
• No, PIC/S does not issue GMP certificates; national authorities issue certificates
• Yes, but only for manufacturers outside member countries
• No, PIC/S only issues marketing authorizations

Correct Answer: No, PIC/S does not issue GMP certificates; national authorities issue certificates

Q6. How does PIC/S promote mutual acceptance of inspection outcomes among members?

• By mandating that members accept each other’s decisions without question
• By providing harmonised inspection standards, training, model reports and encouraging reliance on fellow members’ inspections
• By centralising all inspection data under PIC/S control
• By financially compensating authorities for accepting foreign inspection reports

Correct Answer: By providing harmonised inspection standards, training, model reports and encouraging reliance on fellow members’ inspections

Q7. Which entities are eligible for PIC/S membership?

• Any pharmaceutical manufacturing company with international sales
• National competent authorities responsible for GMP inspection activities
• Universities offering pharmaceutical courses
• Private auditing firms specialised in GMP

Correct Answer: National competent authorities responsible for GMP inspection activities

Q8. What is the PIC/S Committee?

• A panel of industry representatives setting commercial standards
• The main decision-making body composed of representatives of member inspectorates
• A consumer advocacy group advising on drug pricing
• An advisory board of pharmaceutical company CEOs

Correct Answer: The main decision-making body composed of representatives of member inspectorates

Q9. Which of the following is a core activity of PIC/S to improve inspection quality?

• Developing pharmacopoeial monographs
• Conducting inspector training programs, joint assessments and harmonisation workshops
• Issuing marketing authorizations for medicines
• Setting manufacturing cost benchmarks

Correct Answer: Conducting inspector training programs, joint assessments and harmonisation workshops

Q10. Which PIC/S annex provides guidance on computerised systems used in GMP-regulated activities?

• Annex 3
• Annex 11
• Annex 7
• Annex 9

Correct Answer: Annex 11

Q11. During a PIC/S-aligned GMP inspection, an inspector should primarily focus on:

• Negotiating product pricing with the manufacturer
• Assessing manufacturer compliance with GMP principles, risk controls, validation and quality systems
• Approving the company’s marketing materials
• Reviewing the company’s sales forecasts

Correct Answer: Assessing manufacturer compliance with GMP principles, risk controls, validation and quality systems

Q12. What is the relationship between PIC/S and WHO?

• PIC/S is a subordinate body of WHO and follows WHO directives exclusively
• PIC/S is independent but collaborates and cooperates with WHO on regulatory capacity building
• PIC/S competes with WHO for membership of national inspectorates
• PIC/S is the enforcement arm of WHO

Correct Answer: PIC/S is independent but collaborates and cooperates with WHO on regulatory capacity building

Q13. What does “inspection reliance” or “mutual reliance” mean in the PIC/S context?

• One authority takes full legal responsibility for another authority’s decisions
• Authorities use and trust each other’s inspection reports to inform regulatory decisions, reducing duplicate inspections
• Authorities merge their inspectorates into a single entity
• Authorities sell their inspection data to private companies

Correct Answer: Authorities use and trust each other’s inspection reports to inform regulatory decisions, reducing duplicate inspections

Q14. Which PIC/S mechanism is most directly intended to improve inspector competence?

• Mandatory industry internships for inspectors
• Structured training, fellowship programs and peer-to-peer inspector exchanges
• Issuing inspector licences to manufacturers
• Requiring inspectors to publish scientific research annually

Correct Answer: Structured training, fellowship programs and peer-to-peer inspector exchanges

Q15. What does harmonisation of GMP under PIC/S primarily aim to achieve?

• Identical national laws in every member country
• Common interpretations and practical guidance to ensure consistent inspection and enforcement
• Uniform pricing of medicines across members
• Global patent standardisation

Correct Answer: Common interpretations and practical guidance to ensure consistent inspection and enforcement

Q16. Which PIC/S resource helps inspectors produce consistent inspection reports?

• PIC/S model inspection report templates and guidance documents
• National drug formularies
• International pharmacovigilance databases
• Standard operating procedures for clinical trials

Correct Answer: PIC/S model inspection report templates and guidance documents

Q17. If a manufacturer has significant non-compliances identified during a PIC/S-aligned inspection, the typical PIC/S-related response by authorities is:

• Immediate revocation of all product licences by PIC/S
• Follow-up inspections, corrective action plans and possible restrictions on information sharing until compliance is restored
• Automatic imposition of international fines by PIC/S
• Relocation of manufacturing to another country

Correct Answer: Follow-up inspections, corrective action plans and possible restrictions on information sharing until compliance is restored

Q18. Are PIC/S guidelines directly legally binding in member countries without national adoption?

• Yes, PIC/S guidelines override national legislation automatically
• No, PIC/S guidelines are implemented through national regulations and authorities retain legal responsibility
• Yes, but only for small manufacturers
• No, PIC/S guidelines are strictly optional suggestions with no practical use

Correct Answer: No, PIC/S guidelines are implemented through national regulations and authorities retain legal responsibility

Q19. Which PIC/S annex is most relevant when inspecting manufacturers of blood-derived plasma products and vaccines?

• Annex 1
• Annex 2
• Annex 6
• Annex 10

Correct Answer: Annex 2

Q20. Which inspection approach is encouraged by PIC/S to enhance transparency and reduce duplication?

• Uncoordinated, anonymous inspections by third parties
• Joint or collaborative inspections, information exchange and reliance on trusted inspection reports
• Only industry self-inspection without regulatory involvement
• Mandatory global inspections organised by PIC/S annually

Correct Answer: Joint or collaborative inspections, information exchange and reliance on trusted inspection reports

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