This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls.
This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.
Name / Type | Working Capacity (where appropriate) |
---|---|
Mixing Vessel | Capacity: 1000 litres |
Receiving Tank | Capacity: 1200 litres |
Blender | Maximum capacity: 1000 litres |
Heated dryer | Power: 3 kW |
Rotating Impeller with 1.5mm screen | Maximum Speed: 5000 RPM |
Process Step (name) | Parameter | Acceptance Criteria |
---|---|---|
Step: 1
|
Parameter - Capacity |
750 litres
|
Step: 1
|
Parameter - Temperature |
150 °C [Cel] (http://unitsofmeasure.org)
|
Step: 1
|
Controls - pH | pH must be in range 6.9 to 7.1 |
Step: 2
|
Parameter - Maximum Temperature |
40 °C [Cel] (http://unitsofmeasure.org)
|
Step: 2
|
Controls - Water Content | Under 2% |
Step: 3
|
Parameter - Rotational Speed |
2500 rpm
|
Step: 3
|
Controls - Particle Size | Under 200 microns |