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Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs, discussing FDA’s approach to evaluating E&L information
In particular, seven issues were discussed that can negatively impact a new drug product application:
Further advice given was to be clear and detailed in how studies were designed and executed, to ensure use of proper measurement thresholds, and to consider at least three batches of drug product over time. Starting the E&L evaluation and consulting with FDA early are factors for success. E&L is a thrust area for West Analytical Services, having the expertise, staff, and facility, to design and execute E&L studies that meet FDA requirements on behalf of clients. For more on how West can help, please contact an account manager or Technical Customer Service representative.
Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.<br />
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
<p style="margin: 0in 0in 0pt;"><span>Every day, all day, safety matters. Safety never takes a day off. All around us we see safety warnings such as allergens on food labels, use-by-dates on milk and expiration dates on medications. There is no substitute for doing things safely. For pharmaceutical and biotechnology companies offering parenteral drug products, patient safety is the utmost concern.</span></p>
<p>West is committed to partnering with and providing analytical and technical support for customers so that they can successfully develop drug products and deliver them to patients.</p>
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