Complianceonline GMP Rules Quiz

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| By Goodwinjoh
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Goodwinjoh
Community Contributor
Quizzes Created: 1 | Total Attempts: 249
Questions: 10 | Attempts: 249

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Complianceonline GMP Rules Quiz - Quiz

This short quiz tests you on your knowledge of the FDA's GMP rules in 21 CFR 117 GMPs in USP <1078> and PRPs for FSSC 22000.


Questions and Answers
  • 1. 

    An employee need only be given Food Safety training when he first assumes responsibility.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Food Safety training should not be a one-time event for employees. It is important to provide regular and ongoing training to ensure that employees are up to date with the latest food safety practices and regulations. This helps to prevent foodborne illnesses and maintain a safe working environment. Therefore, the statement that an employee only needs to be given Food Safety training when they first assume responsibility is incorrect.

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  • 2. 

    Non-calibrated equipment can be used in our manufacturing process

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Non-calibrated equipment should not be used in the manufacturing process as it may lead to inaccurate measurements, unreliable results, and potential quality issues. Calibrating equipment ensures that it is accurate and reliable, which is crucial for maintaining quality standards and meeting product specifications. Therefore, it is important to use calibrated equipment in the manufacturing process to ensure consistent and reliable results.

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  • 3. 

    Returned products are put on QA Hold, per Entry Control procedure to prevent use until it has been decided how they will be reprocessed or disposed of.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Returned products are put on QA Hold to prevent their use until a decision is made on whether they will be reprocessed or disposed of. This implies that the statement "Returned products are put on QA Hold" is true.

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  • 4. 

    GMPs provide the basic conditions needed for operation, on which we build our________ Plan

    Correct Answer
    Food Safety, HACCP, haccp, food safety
    Explanation
    GMPs (Good Manufacturing Practices) establish the fundamental requirements and guidelines for the operation of a facility. These practices ensure that the necessary conditions are in place to maintain the safety and quality of the products being manufactured. The answer, "Food Safety, HACCP, haccp, food safety," aligns with this explanation as both GMPs and HACCP (Hazard Analysis and Critical Control Points) are essential components in ensuring food safety. By implementing GMPs, companies can create a solid foundation upon which they can develop and implement their food safety and HACCP plans.

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  • 5. 

    Who is responsible for completing an Entry Control Form for deliveries of toluene from Brenntag or Caustic from Harcros?

    • A.

      Shipping/Receiving Dept. only

    • B.

      Warehouse Manager only

    • C.

      Production Tech or Packaging Tech

    • D.

      Any of the above, who was trained to unload a truck

    Correct Answer
    D. Any of the above, who was trained to unload a truck
    Explanation
    The correct answer is "Any of the above, who was trained to unload a truck." This means that anyone from the Shipping/Receiving Dept., Warehouse Manager, Production Tech, or Packaging Tech can be responsible for completing an Entry Control Form for deliveries of toluene from Brenntag or Caustic from Harcros, as long as they have received the necessary training to unload a truck.

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  • 6. 

    We only need to change gloves when they are torn or damaged

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The given statement is false. We need to change gloves not only when they are torn or damaged, but also after each use to maintain hygiene and prevent the spread of germs. Wearing the same gloves for an extended period can lead to cross-contamination and increase the risk of infection. Therefore, it is important to change gloves regularly, even if they appear to be in good condition.

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  • 7. 

     ________ / dedicated smocks are required for packaging

    Correct Answer
    Clean
    Explanation
    In order to maintain cleanliness and hygiene standards during the packaging process, dedicated smocks are required. These smocks help to prevent any contamination or foreign particles from coming into contact with the packaged items. By using clean smocks, the risk of any potential contamination is minimized, ensuring that the packaged products remain safe and sanitary.

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  • 8. 

    Where can cell phones, cosmetics, and tobacco items be stored

    • A.

      Locker room

    • B.

      Lab

    • C.

      Break room

    • D.

      Office area

    • E.

      Warehouse

    Correct Answer(s)
    A. Locker room
    C. Break room
    D. Office area
    Explanation
    These items can be stored in the locker room, break room, and office area because they are commonly used personal items that employees may need access to during their workday. The locker room is a designated area for employees to store their personal belongings, including cell phones and cosmetics. The break room is a common area where employees can take breaks and may need access to their personal items. The office area is where employees typically work and may need to have their cell phones and other personal items nearby.

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  • 9. 

    Hemp jewelry or elastic band bracelets don't pose a food safety risk, so they are allowed.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Hemp jewelry or elastic band bracelets do not have any direct relation to food safety, as they are not consumed or ingested. Therefore, they are not subject to any regulations or restrictions regarding food safety. Thus, they are allowed and do not pose any food safety risk. However, the given answer states that this statement is false, which implies that hemp jewelry or elastic band bracelets do pose a food safety risk, which is incorrect.

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