A date indicating the completion of the final manufacturing process (as defined by the supplier for the particular excipient and process).
See retest date [1] [8] [13] [15] [16]
A visual presentation of the sequence of events that can occur, including decision points.
A molecule resulting from a chemical change in the drug molecule brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Also called decomposition product. [7]
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as “formal experimental design” [9]
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. [9] [11]
The division and movement of excipients from the premises of the manufacturer via distributor(s) to the excipient user. [1] [2]
A company procuring, importing, holding, supplying or exporting excipients. A distributor takes possession and ownership of the excipient(s), including e.g. repackaging, warehousing and transportation, but does not alter the excipients’ physical and/or chemical characteristics e.g. processing / reprocessing. [1] [2]
Drug Master File
The company or individual who has filed a Drug Master File with a Drug Regulatory Authority (e.g. US FDA, EU EMA, etc.). [29]
The system that controls the life cycle of documents; their creation, reviewed, publication, and use, as well as how they are disposed of or retained.
Design of Experiments
A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. [3] [20]
Design Qualification
A finished dosage form, for example, tablet, capsule, or solution, that contains an active ingredient, generally with excipients, that has been prepared for consumer use and that has undergone all stages of production including packaging and labeling. In Europe aka "medicinal product." [1] [2]