Glossary

Card to which a time-temperature indicator is permanently attached, containing information to activate (if necessary) and to interpret the appearance of the indicator. The card may be made from any water-resistant material.

A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.

All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.

The rate and extent to which the active moiety is absorbed from a pharmaceutical dosage form and becomes available at the site(s) of action. Reliable measurements of active pharmaceutical ingredient (API) concentrations at the site(s) of action are usually not possible. The substance in the systemic circulation, however, is considered to be in equilibrium with the substance at the site(s) of action. Bioavailability can therefore be defined as the rate and extent to which the API or active moiety is absorbed from a pharmaceutical dosage form and becomes available in the systemic circulation. Based on pharmacokinetic and clinical considerations it is generally accepted that in the same subject an essentially similar plasma concentration time-course will result in an essentially similar concentration time-course at the site(s) of action.

The batch used to establish bioequivalence or similarity to the comparator product as determined in bioequivalence or biowaiver studies, respectively.

The level and type (objectionable or not) of microorganisms present in raw materials, media, biological substances, intermediates or finished products. Regarded as contamination when the level and/or type exceed specifications.

Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of rate (Cmax and tmax) and extent of absorption (area under the curve), after administration of the same molar dose under the same conditions, are similar to such a degree that their effects can be expected to be essentially the same.

A test that determines the equivalence between the multisource product and the comparator product using in vivo and/or in vitro approaches.

The BCS is a scientific framework for classifying active pharmaceutical ingredients based upon their aqueous solubility and intestinal permeability. When combined with the dissolution of the pharmaceutical product, the BCS takes into account three major factors that govern the rate and extent of drug absorption (exposure) from immediate-release oral solid dosage forms: dissolution, solubility and intestinal permeability.

An active pharmaceutical ingredient (API) for which the highest dose recommended by WHO (if the API appears on the WHO Model List of essential medicines (EML)) or highest dose strength available on the market as an oral solid dosage form (if the API does not appear on the EML) is soluble in 250 ml or less of aqueous media over the Ph range of 1.2–6.8 at 37 °C (8).

The term biowaiver is applied to a regulatory drug approval process when the efficacy and safety part of the dossier (application) is approved based on evidence of equivalence other than through in vivo equivalence testing.

A multi-dose container consisting of two layers, of which one is shaped to contain the individual doses. Strips are excluded.

Any pharmaceutical product that has completed all processing stages up to, but not including, final packaging.