First, explain how you would validate the following aspects of a GMP plant: Facilities, Utilities, Equipment, Computer Control Systems, Methods, Operators. Which of the listed features fits into these categories? How do you qualify the design, installation, operation, process, and/or re-qualify each of the listed features in the homework. Second, describe how you would write protocols designed to validate each feature.
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(A new, hypothetical GMP plant has the following features:
- Incoming warehouse for ingredients and components
- Outgoing warehouse for storage and shipping of final product
- Employee cafeteria
- Quality Control laboratory and test instruments
- Air handling system for production areas
- Air handling system for office areas
- Production equipment
- Maintenance shop
- Nitrogen, compressed air and vacuum systems for manufacturing areas.
- A product to be manufactured
- Test methods to evaluate the product
- Office area for production manager
- Office area for accounting people
- Manufacturing area
1) Describe how this plant should be validated. Include those features above that require validation. Where appropriate, indicate the sequence that should be followed.
2) Describe the types of protocols that should be required for each feature discussed.
