The regulatory requirements concerning the control of Extractables and Leachables (E&L) in pharmaceutical products are becoming more and more stringent. The European Pharmacopoeia has recently introduced new chapters on E&L, while the US Pharmacopeia (USP) is currently working on a new chapter on leachables. In addition, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has also published a guideline entitled "M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". In order to ensure patient safety, it is essential that pharmaceutical companies have a robust E&L control strategy in place. This should include the identification and characterization of potential E&L sources, as well as the implementation of suitable analytical methods for their detection and quantification.
The Extractables and Leachables in Pharmaceutical Manufacturing Masterclass sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/ leachable study necessary?”, “How do I choose appropriate extraction conditions?” and “How low do I need to go in terms of concentration/amount?”.
Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.
The course includes workshops and interactive discussions.
The Extractables and Leachables in Pharmaceutical Manufacturing Masterclass sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/ leachable study necessary?”, “How do I choose appropriate extraction conditions?” and “How low do I need to go in terms of concentration/amount?”.
Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.
The course includes workshops and interactive discussions.
