Manufacturing Authorisation Holders
Various operations, such as processing, packaging, labeling, and testing. [1] [8] [13] [15] [16]
Manufacturer means party (raw material, excipient, drug product) who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging or repackaging of a product. [13] [19]
Submissions to a drug regulatory authority (such as the United States Food and Drug Administration, Health Canada, and the Japanese Pharmaceutical and Medical Devices Agency) that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Intended for incorporation by reference into a new drug application, supplemental new drug application, abbreviated new drug application, investigational new drug application, or biological license application. [21] [29]
A chemical that has many industrial uses which became a concern in 2008 due to incidents of product being adulterated with melamine to falsify analytical test results, resulting in contaminated pharmaceutical supply chains. It is therefore a contamination concern. [EIP]
Ministry of Health, Labour and Welfare (Japan)
Contains starting materials of mineral origin.
A mixed excipient is defined as a simple physical mixture of two or more compendial or non-compendial excipients produced by means of a low- to medium-shear process where the individual components are mixed but remain as discrete chemical entities, i.e., the nature of the components is not chemically changed.
Products resulting from the physical combination of multiple excipients, often through a mixing operation and the nature of the processing is such that the materials are not co-processed together.
Standard that specifies the quality attributes of an excipient, drug substance or drug product. Typically includes the name, description, packaging/storage/labeling requirements and specifications.
A toxic secondary metabolite produced by organisms of the fungus kingdom. A contamination concern which is often tested in final drug product. [EIP]
