Describes a means to reveal any interference with the integrity of the finished packaged excipient and designed to make improper opening of an excipient’s packaging evident to the purchaser.
Document in which an excipient manufacturer describes the type(s) of technically unavoidable particle(s) found in the excipient, along with its(their) origin from a particular manufacturing process or product. A TUPP includes results of prior investigations of various particles, results of risk assessments, raw material characterization, unavoidable particles from product packaging, etc. [37]
Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (examples are size, shape, color, number, texture), AND: 1. Are inherent to the excipient manufacturer’s process, product or raw materials. 2. Are technically unavoidable [37]
Therapeutic Goods Administration
Ability to determine the history, application or location that is under consideration, for example, origin of materials and parts, processing history or distribution of the product after delivery. [1]
TSEs are fatal, subacute degenerative diseases of humans and animals with characteristic neuropathology (spongiform change and deposition of an abnormal form of a prion protein present in all mammalian brains). [35]
Toxic Substances Control Act
Transmissible Spongiform Encephalopathy
Technically Unavoidable Particle Profile
