High Potency & Oncology
Personnel airlock and de-gowning: URS and qualification document flow
The User Requirement Specification is the first document in the qualification set, and the one every later verification traces back to. Pharma4i generates the URS today. The rest of this flow is shown so the scope is clear; those documents are marked Soon and are not produced by the product.
- Generated by Pharma4i today
- Not generated yet — marked Soon
- Connector lines show which documents trace back to the URS.
Qualification document flow for a personnel airlock and de-gowning.
Your URS is the input to every document to its right. Each requirement carries an ID so verification can be traced back to it.
What is specific to a personnel airlock and de-gowning
Containment Performance Verification (FAT) CPV-FAT
Surrogate powder testing to a stated industry containment-performance protocol (SMEPAC-style), with results reported as an 8-hour TWA against the stated occupational exposure band.
Containment Performance Verification (SAT) CPV-SAT
Site testing is what the exposure assessment relies on: works results do not account for room airflow, operator technique or the installed extract system.
The document set
| Document | Abbr. | Owner | Purpose | Traces to URS | Status |
|---|---|---|---|---|---|
| User Requirement Specification | URS | user | States what the equipment must do, in verifiable requirements owned by the user. | — | Available |
| Quality Risk Assessment | QRA | joint | Identifies risks to product quality and patient safety, and sets qualification scope. | Yes | Soon |
| Functional Specification | FS | supplier | Describes the functions the supplier will provide to satisfy each requirement. | Yes | Soon |
| Design Specification | DS | supplier | Records how those functions are engineered, in detail sufficient to build from. | Yes | Soon |
| Design Qualification | DQ | joint | Verifies the proposed design against the URS before fabrication is released. | Yes | Soon |
| Factory Acceptance Test | FAT | supplier | Tests the assembled equipment at the supplier works before shipment. | Yes | Soon |
| Containment Performance Verification (FAT) | CPV-FAT | supplier | SMEPAC surrogate testing at the works to demonstrate the containment target is achievable. | Yes | Soon |
| Site Acceptance Test | SAT | joint | Repeats critical tests on site after delivery and connection to site services. | Yes | Soon |
| Containment Performance Verification (SAT) | CPV-SAT | joint | Repeats SMEPAC surrogate testing on site with the installed extract and room conditions. | Yes | Soon |
| Installation Qualification | IQ | user | Documents that the equipment is installed as specified, with services verified. | Yes | Soon |
| Operational Qualification | OQ | user | Demonstrates the equipment operates across its specified ranges. | Yes | Soon |
| Performance Qualification | PQ | user | Demonstrates sustained performance with the intended product and process. | Yes | Soon |
| Validation Summary Report | VSR | user | Concludes the qualification, resolves deviations and releases the equipment for use. | Yes | Soon |
| Periodic Review / Requalification | PR | user | Confirms at intervals that the equipment remains in its qualified state. | Yes | Soon |