What is 'substance' in SAP IS-PHA-REG - SAP for Identification of Medicinal Products?

substance - Overview

• Component: IS-PHA-REG

• Component Name: SAP for Identification of Medicinal Products

• Description: A composition or single element using one or more of five types of elements: chemical, protein, nucleic acid, polymer, or structurally diverse substances.

substance - Details

• 
  Key Concepts:
  Substance is a term used in the Identification of Medicinal Products (IDMP) component of SAP for Pharmaceuticals (IS-PHA-REG). It is a generic term used to refer to the active ingredients in a medicinal product. It is also used to refer to the excipients, which are inactive ingredients that are added to the active ingredients to form a complete medicinal product. 
  
  How to use it:
  In SAP for Pharmaceuticals, substances are used to identify and track the active and inactive ingredients in a medicinal product. This information is used to ensure that the product meets regulatory requirements and is safe for use. The substances are also used to generate reports on the composition of the product, which can be used for quality control purposes. 
  
  Tips & Tricks:
  When entering substance information into SAP for Pharmaceuticals, it is important to ensure that all relevant information is included. This includes the name of the substance, its concentration, and any other relevant information such as its source or manufacturing process. 
  
  Related Information:
  The IDMP component of SAP for Pharmaceuticals also includes other terms such as “packaging” and “manufacturer” which are related to substances. It is important to understand how these terms interact with each other in order to ensure that all relevant information is captured in SAP for Pharmaceuticals.