1.1 This guide described the scientific procedure underlying integrative interpretation of all relevant data of an active pharmaceutical ingredient (API) that takes into account specific characteristics (e.g. potency, toxicological profile, and pharmacokinetics) of each substance, and assigns a numerical value which is used further in the quality risk management of cross contamination during the manufacture of different products in the same manufacturing facilities. 1.2 This guide describes general guidance for the HBEL document. It should serve the involved experts as reference for HBEL derivations and should harmonize the different approaches and nomenclature as far as possible. 1.3 The principles in this guide may be applied to drug products or API and biopharmaceuticals 1.4 This guide may be used in the quality risk management of cross contamination during the manufacture of different products in the same manufacturing facilities 1.5 The principles in this guide may be applied during the development and manufacturing of a new product or generic product. 1.6 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.

Keywords

Rationale

This guide will standardize the derivation of HBELs, define the qualifications required for performing the derivation and the minimum requirements for documentation of the derivation. The guide will be used by regulatory inspectors (e.g., FDA, EMA, etc.)for evaluating the HBELs they find during inspections.