Complianceonline FDA Pharma GMP Rules Quiz

Explanation
Both documentation and computer systems should be used to identify permanent pipework in a manufacturing facility. Documentation can provide detailed information about the pipework, such as its location, purpose, and specifications. Computer systems can be used to store and track this information, making it easily accessible and searchable. By utilizing both methods, the facility can ensure accurate and up-to-date identification of the permanent pipework, facilitating maintenance, repairs, and overall management of the facility.

Explanation
This statement is false because training should not be limited to just when an employee first assumes responsibility. Training should be an ongoing process throughout an employee's tenure to ensure they have the necessary skills and knowledge to perform their job effectively. Continuous training helps employees stay updated with new technologies, industry trends, and best practices, allowing them to adapt to changing circumstances and improve their performance over time.

Explanation
When samples are taken from different parts of a container, it is important not to composite them. This means that the samples should not be mixed together. This is because the samples taken from different parts of the container may have different characteristics or contaminants. By keeping the samples separate, it allows for a more accurate analysis of each individual sample and provides a better understanding of the overall contents of the container.

Explanation
Deviation and investigation reports should be reviewed before a batch is released, not after. This is to ensure that any issues or deviations from standard procedures are addressed and resolved before the batch is released for distribution or use. Reviewing these reports after the batch has been released would be counterproductive and could lead to potential risks or quality issues going unnoticed. Therefore, the given statement is false.

Explanation
Non-calibrated equipment should not be used in pharma manufacturing facilities. Calibrated equipment is necessary to ensure accurate and reliable measurements, which are crucial in pharmaceutical manufacturing to maintain quality and safety standards. The use of non-calibrated equipment can lead to inaccurate results, compromised product quality, and potential risks to patient health. Therefore, it is important to use calibrated equipment in pharma manufacturing facilities.

Explanation
Returned drugs need to be quarantined in a specific, demarcated area to ensure they are kept separate from other stored products. This is important to prevent any potential contamination or mixing of the returned drugs with the regular stock. By quarantining them, it allows for proper inspection, verification, and appropriate disposal or reintegration into the inventory if deemed safe. This practice helps maintain the integrity and safety of the stored products and ensures compliance with regulations and quality control measures.