Either primary or secondary packaging materials which also have the function of preventing the permeation of gases, moisture or volatile concomitant components into or from the excipient. NOTE: Shipping pallets are not considered secondary packaging. [Significant Change]
A specific quantity of material produced in a process or a series of processes so that it may be expected to be uniform in character and quality, within specified limits. In the case of a continuous process, a batch may correspond to a defined fraction of the production. The batch size may be defined by a fixed quantity or by the amount produced in a fixed time interval. [1] [8] [13] [16] [17]
A method of manufacturing where the products are made as specified groups or amounts, within a time frame. The batch size may be defined by a fixed quantity or by the amount produced in a fixed time interval.
A unique combination of numbers, letters and/or symbols that identifies a batch and from which the production and distribution history can be determined. [1] [8] [13] [15] [16]
(refer to batch manufacture) [1]
Bundesinstitut für Arzneimittel und Medizinprodukte (Germany)
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, starting materials, excipients, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected. [EIP] [8]
Any substance produced from animal or vegetable materials including starting materials and processing materials where the latter can come into contact with the excipient.
The US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) which directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. [27]
The sufficient mixing of materials to produce a homogeneous mixture.
A slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. [28]
British Pharmacopoeia
Bulk Pharmaceutical Excipient
British Retail Consortium
Bovine Spongiform Encephalopathy
