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Questions and Answers
Which department is responsible for ensuring proper storage of materials?
Which department is responsible for ensuring proper storage of materials?
- Production
- Human Resources
- Sanitation (correct)
- Maintenance
What is the definition of active production areas?
What is the definition of active production areas?
- Areas where visitors are allowed to enter
- Areas where workers take breaks
- Areas containing exposed product or materials that could be contaminated (correct)
- Areas where managers and supervisors work
What is the purpose of Personal Protective Equipment (PPE) in the manufacturing process?
What is the purpose of Personal Protective Equipment (PPE) in the manufacturing process?
- To improve worker productivity
- To reduce the cost of manufacturing
- To ensure worker safety and product quality (correct)
- To promote worker comfort
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Study Notes
- The policy sets forth procedures for Good Manufacturing Practices at Biovation Labs.
- The policy aims to produce quality dietary supplements and promote safety and hygiene among workers.
- The policy applies to all BVL facilities and everyone, including visitors and contractors, must adhere to GMPs in active production areas.
- Different departments have specific responsibilities, such as maintenance, human resources, and production.
- Managers and supervisors provide training, monitor compliance, initiate corrective action, and ensure visitors and workers follow cGMP regulations.
- The Quality Unit verifies job descriptions, training, and compliance with cGMP regulations.
- Sanitation and warehouse departments are responsible for cleanliness and proper storage of materials.
- Active production areas are defined as areas containing exposed product or materials that could be contaminated.
- cGMP refers to current Good Manufacturing Practices enforced by the FDA.
- Personal Protective Equipment (PPE) must be worn by operators for safety and product quality.
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