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.