Design Review of Plants
Purpose
To carefully review the basic concept and the design of a plant based on general documents such as layout drawings, Master Plans, facility description, URS, etc, and/or on-site checks and to provide comments and details that helps – if necessary - to modify the design of the plant to finally comply with the relevant GMP requirements.
Prerequisites
- Types, intended uses and no. of products to be produced in the plant should be decided.
- First design of plant, premises and rooms should be in place (conceptual or basic design).
- Basic engineering documentation (e.g. actual P&IDs, layout drawings, equipment lists) should be in place.
- URS based on a detailed risk assessment should be available
Procedures
- Discuss with client about their requirements and collect the required information for quotation (Signing of Secrecy Agreement recommended).
- Prepare an offer (fixed rate, depends on the size of the plant and the depth of design review).
- Sign the contract and project commence.
- Collect the relevant documents and drawings and determine if the basic concept and plant design complies with GMP requirements, i.e. whether the design can avoid mix-up and cross contamination, the material & personnel flow and the layout of different hygiene zones are logically arranged and designed.
- Check details of planned HVAC system, e.g. filter types, alarms, air locks, planned monitoring of clean rooms, a.o.
- Check the kind of utilities foreseen for the plant including detailed design specification (e.g. water systems, steam generator, pressurized air generator)
- Check the logistic with view to the storage area for incoming goods and outgoing products and the environmental conditions of the related sampling areas.
- Check the arrangement and design of warehouses including tank farms and storage areas for special goods.
- Dependent on the progress of the project and the client’s request, perform a detailed 2-3 days on-site design review to check key components in detail, and/or already fixed construction of clean rooms, selection of the correct equipment, spot view check of key equipment. This includes but is not limited to in depth discussion with client and – where appropriate – active consultancy services or training to improve and optimize the ongoing work (Enhanced design review of individual equipment and parts of the plant based on construction drawings, P&ID’s, isometric drawings, and others needs more time, dependent on the number of equipment and depth of review. This can be offered separately if necessary).
- Check the basic concept for qualification & validation and assure that those documents are available and complete which urgently must be drawn up right at the beginning of the project (e.g. Validation Master Plan, URS, Risk Assessment).
- Prepare the design review report including a to-do list.
- Discuss the results with the client during handover of the report.
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What is GMP
Design Review
