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Quizzes > Health & Medicine

GMP Quiz for Employees: Check Your Compliance Knowledge

Quick, free GMP training quiz with 15 questions. Instant results.

Editorial: Review CompletedCreated By: Michael AikenUpdated Aug 23, 2025
Difficulty: Moderate
Questions: 20
Learning OutcomesStudy Material
Colorful paper art displaying questions for Employee GMP Knowledge Test quiz

This GMP quiz helps you check how well you follow Good Manufacturing Practice at work and spot gaps before an audit. Answer 15 multiple-choice questions on hygiene, documentation, and contamination control, then see instant results with brief tips. Building your safety toolkit? Explore the HACCP quiz and the medication safety quiz for more practical checks.

Which primary objective best describes Good Manufacturing Practices (GMP) in a regulated facility?
To ensure products are consistently produced and controlled to quality standards
To optimize marketing claims for product labels
To reduce production costs and increase throughput
To eliminate all human involvement in manufacturing
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Which document records the actual steps performed and data collected for a specific batch?
Master Batch Record (MBR)
Equipment User Manual
Validation Master Plan (VMP)
Executed Batch Record (EBR) or Batch Production Record (BPR)
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Which activity must occur immediately before starting a new packaging order on a line?
Preventive maintenance of all line equipment
Annual GMP training for all staff
Line clearance and reconciliation of previous materials
Full product recall simulation
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Which statement best defines a deviation in GMP?
A planned improvement to increase yield
Any unplanned departure from an approved instruction or expected result
An observation from an external regulatory inspection only
Any change to a procedure approved through change control
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CAPA in the GMP context stands for what?
Control and Process Alignment
Corrective and Preventive Action
Compliance and Policy Assessment
Calibration and Performance Adjustment
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Which of the following is an example of Good Documentation Practice (GDP)?
Writing entries contemporaneously in indelible ink with dated signature/initials
Backdating entries to match target timelines
Using pencil so errors can be erased
Leaving fields blank to fill later
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Which control helps prevent cross-contamination in multiproduct facilities?
Using identical labels for all products
Shared utensils without cleaning
Open door policy between rooms
Dedicated equipment or validated cleaning between products
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What does ALCOA+ primarily relate to in GMP?
Data integrity principles for records and entries
Supplier qualification criteria
Environmental monitoring alert levels
Equipment lifecycle management
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Which tool is most commonly used to identify root causes during a deviation investigation?
Gantt chart
Ishikawa (fishbone) diagram
Monte Carlo simulation
Payback period analysis
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Who is ultimately responsible for product release to the market in a GMP system?
Maintenance supervisor
Any operator who packaged the product
Marketing department
Quality unit or Qualified Person (as applicable)
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Which parameter is most critical to maintain pressure differentials in cleanrooms?
Positive or negative pressure cascades as specified by room classification
Color of the gowning garments
Day of the week
Employee seniority
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What is the primary purpose of environmental monitoring in sterile areas?
To determine raw material pricing
To assess microbial and particulate contamination risk to product
To measure operator productivity
To verify the HVAC energy consumption
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Which activity must be controlled by change control in GMP?
Planned change to a critical process parameter or procedure
Routine cleaning within approved SOPs
Unplanned equipment breakdown
Correcting a recording error with a single-line strike-through
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What is the correct action when an Out-of-Specification (OOS) test result is obtained?
Repeat testing until a passing result is found
Immediately discard the product without investigation
Ignore the result if the batch history looks good
Initiate an OOS investigation per SOP to assess lab and manufacturing causes
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Which requirement is central to 21 CFR Part 11 for electronic records and signatures?
Validated systems with audit trails and secure, unique user IDs
Paper backup not required and no controls needed
Editable audit trails
Unlimited shared user accounts
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Which is the most appropriate acceptance criterion for cleaning validation to control carryover?
Residue levels below established MACO and microbiological limits
Operator discretion each batch
Residue levels equal to previous product potency
No visible residue only
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Which statement correctly differentiates retest date from expiry date for an API?
Expiry applies only to excipients
Retest date is when the API must be destroyed
Retest date is when the API should be tested to confirm suitability; expiry is when it should not be used
Both terms mean the same
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Which component is essential in a validated computerized system supporting GMP?
Periodic review of audit trails and system access logs
Shared passwords for shift teams
Unrestricted data editing by administrators
Turning off time synchronization to save power
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Which activity is part of process validation lifecycle Stage 3 Continued Process Verification?
Factory acceptance testing of equipment
Writing the marketing plan
Defining user requirements
Ongoing monitoring of process performance and product quality data
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Which water quality is typically required for final rinse in sterile manufacturing equipment cleaning?
Purified Water or Water for Injection as specified by procedure
Any available water
Distilled water from domestic sources
Potable water
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Learning Outcomes

  1. Identify core GMP principles in workplace settings.
  2. Apply hygiene and sanitation standards accurately.
  3. Demonstrate proper equipment cleaning procedures.
  4. Analyse potential contamination risks and controls.
  5. Evaluate documentation best practices for compliance.
  6. Master protocols for handling raw materials correctly.

Cheat Sheet

  1. Understand the Core Principles of Good Manufacturing Practices (GMP) - Think of GMP as the ultimate recipe book that makes sure every product you create is safe and consistent, just like following a trusted cooking guide. You'll learn about hygiene rules, equipment maintenance, and quality checkpoints that keep contamination at bay.
  2. Master Proper Hygiene and Sanitation Standards - Cleanliness is your first line of defense against unwanted guests - like bacteria or other nasties - in your facility. Follow a seven-step cleaning protocol that includes pre-cleaning, washing, rinsing, sanitizing, and drying to keep every surface sparkling.
  3. Implement Effective Equipment Cleaning Procedures - Imagine your equipment is a prized gadget: regular disassembly and deep-cleaning will keep it running smoothly and free from cross-contamination. Learn how to validate your cleaning steps and choose the right agents so you won't leave any hidden residues behind.
  4. Identify and Control Potential Contamination Risks - Become a contamination detective by spotting hazards from raw ingredients, machinery, or even your co-workers. Set up sealing, segregation, and environmental monitoring to stop troublemakers before they invade your workspace.
  5. Maintain Accurate and Comprehensive Documentation - Good record-keeping is like keeping a high-score list: it tracks every cleaning session, who did it, and what chemicals were used. This traceability helps you prove compliance and quickly solve any mystery if quality issues pop up.
  6. Handle Raw Materials Correctly - Treat your raw materials like precious ingredients - inspect, qualify, and store them under ideal conditions so they don't spoil or introduce contaminants. Following strict supplier checks and storage rules ensures you start every batch on a clean slate.
  7. Understand the Importance of Equipment Design in Sanitation - Just as a non-stick pan makes cleanup a breeze, well-designed machinery helps you reach every nook and cranny when sanitizing. Regular inspections for hard-to-clean spots ensure you're not leaving sneaky germs behind.
  8. Implement Pest Control Measures - Channel your inner superhero by setting up traps, sealing entry points, and keeping waste under control to repel pests. A robust pest program keeps rodents and insects out of your production story.
  9. Ensure Proper Waste Management - Think of waste like hot lava - you want it removed fast and sorted properly to avoid accidents or contamination. Implement segregation, scheduled pickups, and safe disposal methods to keep your facility tidy and risk-free.
  10. Stay Updated with Regulatory Requirements - GMP rules can change faster than the latest social media trends, so make it a habit to check in with official sources. Staying informed ensures you're always playing by the rules and ready for any audits.
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