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ADI

Accepted Daily Intake is the estimated amount of a given material (e.g., food additive or excipient), expressed on a bodyweight basis that can be ingested on a daily basis over a lifetime without appreciable risk to human health.

Note that the statement “without appreciable risk” is used here to mean that based on the current knowledge, there is certainty that no harm will result, even after a lifetime of exposure to the additive concerned.

ADI is usually given as a range of 0-x milligrams per kilogram of bodyweight per day.

Additive

Technically used in relation to food products and refers to substances intentionally added to foods the use of which results in their becoming components or affecting the characteristics of the food product.

Additives may or may not be regulated which determines if premarket approval is required prior to use. Furthermore, additives may be direct additives, for instance, incorporated into a product for a specific purpose, such as emulsification or indirect additives, either because they are carried over or are part of the packaging, storage or other handling processes.

GMP

Good Manufacturing Practice, the framework of standards that manufacturers of medicines or medicinal components are required to meet in their production processes. Regulatory agencies, such as the FDA and EMA, usually coordinate inspections to verify compliance with these GMP standards.

In Europe and United States, all manufacturer of medicines intended for the those markets, irrespective of their location, are expected to comply with GMP to ensure that medicines are consistent in quality, are safe and meet the stipulations of their marketing authorisation or clinical trial authorisation.

Monograph

A monograph is a section in a pharmacopoeia or other compendium that lays down the quality attributes of excipients, active pharmaceutical ingredients or finished medicinal products. The most important of these attributes include identity, strength, tests and purity. It is important to remember that compliance with a monograph does not equate with a licence to market that product in a specific geography. Approval for sale is a separate process undertaken by a regulatory agency.

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