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This glossary defines the terms a buyer meets when choosing a peptide or active pharmaceutical ingredient manufacturer. Each definition is one or two sentences and describes what the term means in manufacturing, documentation or US regulation.
Made in USAA stock product a manufacturer has already made and tested, supplied under the buyer's brand.
A product made to order for one brand, to an agreed specification, as a dedicated lot.
The substance intended to become the active part of a finished drug. Also called a bulk drug substance.
Another name for an active pharmaceutical ingredient, and the term used in US compounding law.
A molecule made of amino acids linked in a chain, shorter than a protein.
A method of building a peptide one amino acid at a time on a solid resin. The finished peptide is then removed from the resin and purified.
Freeze-drying: removing water from a frozen product under vacuum to leave a dry solid.
A defined quantity of product made in one production run and intended to be uniform. A lot number identifies it. Also called a batch.
The list of tests, methods and acceptance limits a lot must meet before it is released.
A document issued for one lot that lists each test performed, the method, the specification and the result.
High-performance liquid chromatography, a method that separates the components of a sample. It is commonly used to measure purity.
A method that measures the mass of molecules. It is commonly used to confirm identity.
The group within a manufacturer that approves or rejects each lot, independent of production.
Current Good Manufacturing Practice, the quality requirements FDA enforces for drug manufacturing.
The international guideline on good manufacturing practice for active pharmaceutical ingredients, published by FDA as guidance for industry.
The registration a drug manufacturing site files with FDA. Registration does not denote FDA approval.
The FDA Establishment Identifier, a number FDA assigns to a facility.
A confidential submission to FDA describing how a substance is made and controlled. FDA neither approves nor disapproves a drug master file.
The first segment of a National Drug Code, assigned by FDA to the firm named on the label.
The part of federal law covering pharmacies that compound for identified patients on prescriptions.
The part of federal law covering outsourcing facilities, which register with FDA and follow cGMP.
FDA's list of bulk drug substances a 503A compounder may use when a substance has no USP or NF monograph and is not a component of an FDA-approved drug.
A written contract between a manufacturer and its customer that sets out each party's quality responsibilities.
The written description of where a product's manufacturing steps were performed, supplied to customers for use on their labels.
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