Organization and personnel responsibilities under cGMP MCQs With Answer

Organization and personnel responsibilities under current Good Manufacturing Practices (cGMP) are critical for ensuring the consistent production of safe, effective pharmaceutical products. This blog offers M.Pharm students a focused set of multiple-choice questions designed to deepen understanding of how organizational structure, defined responsibilities, and personnel practices support GMP compliance. Questions cover topics such as the independent quality unit, segregation of duties, job descriptions, training, medical surveillance, delegation of authority, documentation responsibilities, contractor oversight, and management accountability. Use these MCQs to test and reinforce practical knowledge needed for quality assurance roles and regulatory inspections in the pharmaceutical industry.

Q1. Which organizational element is primarily responsible for the final approval or rejection of drug batches under cGMP?

• The Production Manager
• The Quality Control Laboratory Technician
• The Independent Quality Unit (Quality Assurance)
• The Regulatory Affairs Specialist

Correct Answer: The Independent Quality Unit (Quality Assurance)

Q2. Under cGMP, what is the main purpose of detailed job descriptions for personnel?

• To serve as legal contracts for employment
• To define responsibilities, required qualifications, and lines of authority
• To replace the need for practical training
• To document employee salaries and benefits

Correct Answer: To define responsibilities, required qualifications, and lines of authority

Q3. Which practice helps prevent conflicts of interest and ensures independent product release decisions?

• Having production staff perform routine QC testing
• Consolidating QC and production leadership under one manager
• Maintaining an independent quality unit with authority to approve or reject batches
• Outsourcing all quality functions to third parties

Correct Answer: Maintaining an independent quality unit with authority to approve or reject batches

Q4. When should GMP training be provided to personnel according to cGMP principles?

• Only during initial hiring
• Only when a regulatory inspector visits
• At hiring, periodically thereafter, and when duties change
• Only for management-level staff

Correct Answer: At hiring, periodically thereafter, and when duties change

Q5. Who is typically responsible for ensuring that contractors working on production equipment follow site GMP policies?

• The site security team
• The contractor’s project manager exclusively
• The designated site representative (e.g., engineering or production manager) with oversight from Quality
• The sales department

Correct Answer: The designated site representative (e.g., engineering or production manager) with oversight from Quality

Q6. Which document formally assigns authority and responsibility across an organization to meet cGMP requirements?

• Standard Operating Procedure (SOP) for cleaning
• Organizational chart and role-specific SOPs/job descriptions
• Employee handbook for benefits
• Purchase order terms and conditions

Correct Answer: Organizational chart and role-specific SOPs/job descriptions

Q7. What is the expected role of senior management in a GMP-compliant organization?

• To delegate all quality issues to junior staff
• To set quality policy, ensure resources, and promote a quality culture
• To focus primarily on marketing and sales targets
• To perform routine QC testing

Correct Answer: To set quality policy, ensure resources, and promote a quality culture

Q8. Which principle is important for preventing contamination by personnel in manufacturing areas?

• Allowing street clothes in cleanrooms for comfort
• Strict gowning procedures, restricted personnel flow, and hygiene monitoring
• Mixing production and administrative activities in the same room
• Minimizing headcount to one person per shift

Correct Answer: Strict gowning procedures, restricted personnel flow, and hygiene monitoring

Q9. How should deputization or temporary assignment of responsibilities be managed under cGMP?

• Temporarily assign without documentation to save time
• Document delegation, ensure competency through training, and define authority limits
• Only informally notify colleagues by email
• Assign only to external contractors

Correct Answer: Document delegation, ensure competency through training, and define authority limits

Q10. Which of the following is a primary responsibility of production personnel under cGMP?

• Approval of final release certificates
• Conducting supplier audits
• Following batch manufacturing records and reporting deviations
• Authorizing regulatory submissions

Correct Answer: Following batch manufacturing records and reporting deviations

Q11. What is the significance of segregation of duties in a GMP organization?

• To reduce communication between departments
• To ensure checks and balances by preventing a single person from controlling multiple related functions
• To promote staff specialization only in administration
• To allow one person to handle procurement and final release to speed up operations

Correct Answer: To ensure checks and balances by preventing a single person from controlling multiple related functions

Q12. Which responsibility belongs to the Quality Control (QC) department rather than Quality Assurance (QA)?

• Setting site quality policy
• Performing analytical testing and generating test reports
• Authorizing batch release
• Approving change control from a quality systems perspective

Correct Answer: Performing analytical testing and generating test reports

Q13. During an inspection, what demonstrates that personnel training is effective?

• Training certificates without linked curricula or assessment
• Documented training records, competency assessments, and evidence of application in work
• Oral assurances from employees only
• Lack of refresher training for experienced staff

Correct Answer: Documented training records, competency assessments, and evidence of application in work

Q14. What action should be taken when dedicated personnel are absent and critical tasks must be performed?

• Assign the tasks to untrained staff to maintain production schedule
• Cancel the batch without further evaluation
• Use a trained and authorized alternate with documented delegation and oversight
• Outsource the task without documentation

Correct Answer: Use a trained and authorized alternate with documented delegation and oversight

Q15. Which of the following best describes the responsibility of personnel in handling deviations?

• Ignore minor deviations and proceed
• Report deviations promptly, document details, and participate in investigation and CAPA
• Only inform the production supervisor verbally
• Delete deviation records after resolving the issue

Correct Answer: Report deviations promptly, document details, and participate in investigation and CAPA

Q16. What is a GMP expectation for medical surveillance of personnel?

• No medical checks are required for GMP facilities
• Periodic medical evaluation and exclusion from certain duties if illness poses a contamination risk
• Only new hires require a medical check once
• Medical surveillance is optional and at employee discretion

Correct Answer: Periodic medical evaluation and exclusion from certain duties if illness poses a contamination risk

Q17. How should changes in organizational responsibilities be controlled under cGMP?

• By informal emails between managers
• Through formal change control, updated job descriptions, training, and communication to impacted staff
• By delaying documentation until audited
• By relying on verbal instruction only

Correct Answer: Through formal change control, updated job descriptions, training, and communication to impacted staff

Q18. What is the role of QA in supplier selection and approval?

• QA has no role; procurement handles everything
• QA defines quality requirements, participates in supplier evaluation, and approves suppliers for GMP materials
• QA only receives invoices from suppliers
• QA approves suppliers solely based on lowest cost

Correct Answer: QA defines quality requirements, participates in supplier evaluation, and approves suppliers for GMP materials

Q19. Which practice is essential for maintaining accountability of personnel in GMP recordkeeping?

• Allowing any staff to sign records without identification
• Requiring dated signatures, printed names, and job titles with electronic audit trails where applicable
• Storing records without indexes
• Erasing initials if an error is fixed

Correct Answer: Requiring dated signatures, printed names, and job titles with electronic audit trails where applicable

Q20. In the context of cGMP, what is a key responsibility of the quality unit during investigation of product complaints?

• Ignore complaints that are infrequent
• Lead the investigation, determine root cause, implement corrective actions, and assess impact on product quality
• Forward complaints directly to marketing for customer relations only
• Close complaints without documentation if resolved verbally

Correct Answer: Lead the investigation, determine root cause, implement corrective actions, and assess impact on product quality

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