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Establishing Health-Based Exposure Limits for Active Pharmaceutical Ingredients.

Practically speaking, the guideline covers aspects needed to address the safety of human patients and, for veterinary medicines, target animals potentially exposed to residual active substances via medicinal products.  The health-based exposure limit for a given API is the permitted daily exposure (PDE) value.  The PDE value is used to help establish cleaning validation requirements in manufacturing facilities (i.e., determine limits that have to be met).  Derivation of a PDE value for a given active substance requires examination and interpretation of toxicology/safety data, pharmacology (efficacy) data, information on the route of administration, and other considerations.The new EMA guideline took effect on June 1, 2015 for medicinal products being introduced into shared manufacturing facilities.  For medicinal products intended for human use and already in production in shared manufacturing facilities, the guideline applied starting November 2015.  Manufacturers of APIs need to be aware of the guideline’s expectations regarding data collection and assessment, methods used to derive PDE values, and reporting requirements.Scientists in the Pharmaceutical & Healthcare group at Intertek Scientific & Regulatory Consultancy are well-positioned to perform assessments and prepare reports that are compliant with the new EMA guideline. 

Our team has recently worked with several clients to prepare assessment reports tailored specifically to the requirements of the new EMA guideline in order to derive PDE values which can be used to assist cleaning validation efforts.  In addition, over the past few years our team has prepared in excess of 200 toxicological risk assessment reports.

These have included the derivation of PDE values or equivalent exposure limits using methodologies consistent with the new EMA guideline, the development of science-based rationales to support specifications for active compounds, and the assessment of safety risks for extractable/leachable compounds, impurities, and other such substances found in medicines.
Today’s expert blogger is Valentia Lee-Brotherton. Valentia is Director, Toxicology, with Intertek Scientific & Regulatory Consultancy’s Pharmaceuticals & Healthcare team. She brings more than 16 years of experience in the provision of strategic scientific advice, guidance on toxicology issue resolution, and assistance with regulatory agency interactions.To know more visit our site http://allindiayellowpage.com.