Evaluating extractables and leachables has become an increasingly important consideration in drug development following a number of cases in which patients have experienced an adverse reaction not to the drug itself but to a contaminant introduced to a drug from the very materials and packaging that are meant to protect it.
Monomers and additives – antioxidants, plasticisers, and stabilisers – have the potential to migrate and adulterate the final medicinal product, and safety assessment of contaminations induced by the packaging and production process therefore represents a specifically regulated area of concern within a drug product development process and is referred to as the qualification of Extractables and Leachables (E&L).
The evaluation of E&L has become an increasingly important aspect in the FDA’s quality by design (Qbd) initiative for drug design
The evaluation of E&L has become an increasingly important aspect in the FDA’s quality by design (Qbd) initiative for drug design. In particular, Qbd influences the selection of the materials used in the drug production process and the selection of container and closure systems used for product packaging to help maintain product safety, quality, and efficacy.
On 17 May 2012 a free webinar organised by CPhI Worldwide will cover current regulatory guidelines (FDA - PQRI) and provide a general approach to designing extractables and leachables studies for evaluating and qualifying finished containers and the process materials used in pharmaceutical production.
It will review ICH guidelines, as well as the global pharmacopeial requirements and will look at extractables and leachables data sharing (ELSIE) and relevant genotoxins.
Participants in the webinar will gain understanding of the current regulatory requirements and expectations; learn what needs to be taken into consideration when designing an extractables and leachables study, and gain confidence regarding laboratory testing practices and the security of their product and supply chain.
Over the past few years, there has been a considerable effort undertaken by specific industry consortia to translate high level regulatory requirements into industry practice
A presentation by Thomas Egert, research scientist at Boehringer Ingelheim, will provide an overview of the relevance of E&Ls in pharma industry, along with key information on how they are addressed in current worldwide regulations. ‘Over the past few years, there has been a considerable effort undertaken by specific industry consortia to translate high level regulatory requirements into industry practice,’ he says. ‘A summary of these activities will be presented along with relating key consortia publications.’
Andreas Nixdorf, project manager at SGS, will discuss the design of E&L studies to help maintain product safety, quality, and efficacy. His presentation will demonstrate a systematic approach to the evaluation, identification, quantification, and specification setting of extractables and leachables that builds product quality into the manufacturing process. It will also address analytical thresholds of extractables for the evaluation of materials and packaging.
The webinar will be moderated by Hilary Ayshford, managing editor of Manufacturing Chemist and Cleanroom Technology, and will take place on 17 May at 9:30 London/10:30 Berlin/14:00 Mumbai/16:30 Shanghai time. To register for your free place, click here.