Manufacturing Authorisation Holders
Various operations, such as (re) processing, (re) packaging, (re) labeling, and testing. [1] [8][13] [15] [16]
Manufacturer means party (raw material, excipient, active ingredient, medicinal product) who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging or repackaging of a product. [13] [19]
Submissions to a regulatory authoritythat may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human and/or animal medicinal products [29]
The company or individual who has filed a Drug Master File with a Drug Regulatory Authority (e.g. US FDA, EU EMA, etc.). [29]
A general term used to denote raw materials (reagents, solvents), process aids, intermediate and packaging and labelling materials.[21]
Maximum Daily Exposure
A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. [40]
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.
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.
A product which simulates a group of similar products.[21]
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.
The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the excipient for pharmaceutical use and/or impurities. It may be used for further processing but there must a limit on how many times it can be recycled).[21]
A toxic secondary metabolite produced by organisms of the fungus kingdom.A contamination concern which is often tested in final drug product.
