International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Inactive Ingredient Database
An undesirable material found in an excipient as a consequence of the raw materials, excipient manufacturing process, or excipient degradation. [1] [4][7] [8] [12]
A description of the identified and unidentified impurities present in an excipient.[21]
Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or product conforms to its specifications. [21]
International Nomenclature of Cosmetic Ingredients and Handbook.
The range set based on the desired target.
Equivalent in the qualitative composition profile and the manufacturing, stability and post-administration performance in the given application. [19]
A material produced during steps of the processing of an excipient for medicinal product use that undergoes further molecular change or purification before it becomes an excipient for pharmaceutical use. Intermediates may or may not be isolated. [21]
International Pharmaceutical Excipients Auditing, Inc.
International Pharmaceutical Excipients Council
International Pharmaceutical Excipients Council and the Pharmaceutical Quality Group
Installation Qualification
International Organization for Standardization.
The International Organization for Standardization’s family of standards on environmental management Site and Supply Chain Security Overview – Section 4
International Standards Organization guidelines for a Quality Management System
