API Manufacture, Medicated Animal Feed Manufacture and Manufacture – The act of producing active pharmaceutical ingredients from raw materials. Licensed facilities permitted to prepare animal food with added medications. The act of making something (a product) from raw materials.

SIP Foreign Seller – An establishment engaged in the distribution of an eligible prescription drug that is imported or offered for importation into the United States.

Transfill – The transfer of gas, either in a liquid or gaseous state, from a larger container, or from permanently mounted tanks, into smaller high-pressure cylinders or cryogenic vessels, in a process known as “cascading”. During the transfer, different gases may be mixed together.

Positron Emission Tomography Drug Production – The activity of producing any reagents used in positron emission tomography (PET) diagnostic imaging, including radioactive nuclides, nonradioactive reagent, reagent kit etc.

Particle Size Reduction – The mechanical process of breaking particles into smaller pieces via one or more particle size reduction mechanisms. Milling is the most common process used.

Analysis – Examination and interpretation; the process of identifying an issue to be understood and addressed, modelling the issue, investigating the model results, interpreting the results, and possibly making a recommendation. The concept also refers to the examination and study of a whole in terms of the parts composing it.

Label and Relabel – The action of affixing an identifier to an item or the container for an item. Relabeling an already marketed product by adding to or replacing the original label.

Pack and Repack – Performance of the packaging part of the manufacturing process. To take an item from its packaging and place into a different package, or to add a package over an existing package.

Sterilize – Validated process used to render product free from viable microorganisms.