Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. 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.4 Control of Excipients, subsections 3.2.P.4.5 Excipients of Human or Animal Origin & 3.2.P.4.6 Novel Excipients.
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.
Excipient | Biological Source | Country of Origin | Manufacturer | Suitability for Use |
---|---|---|---|---|
Pegylated glucose | mineral | United Kingdom | Modified Sugar, Inc. | Excipient has been certified for use in human medicinal products |
Excipient | Biological Source | Country of Origin | Manufacturer | Suitability for Use |
---|---|---|---|---|
Deactivated goat albumin | animal | United States of America | Plasma Source, Inc. | Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials. |