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At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”
It is not surprising that there is still confusion on the topic. Guidances, where available, do not give step by step instructions. In addition, drug products and other drug product contact materials are getting more and more complex. So, where should you start?
We know from ICH Q9 that, “The evaluation of the risk should be based on scientific knowledge and ultimately link to the protection of the patient.” Therefore, we should view all work done to characterize extractables and leachables in terms of patient risk.
Starting with component selection we can ask questions such as:
With this information, you have a starting point in order to select the packaging materials that best fit your needs.
Now that you have selected the appropriate components, you can assess extractable information gaps and design fit for purpose analytical evaluations. The point here is not to do less testing, but rather, more focused testing in order to answer any outstanding questions.
Once all the pertinent extractable data has been obtained to understand your materials, you can further organize the information based on risk in order to decide which compounds should be monitored over the shelf life of the drug product and which should not (Leachables phase). Some questions to ask at this stage are:
After the organization of compounds is completed, you can use those justifications to define a leachables testing plan. Methods used to quantitate leachables should be validated and detection/quantitation levels should be meaningful in terms of patient safety. USP <1664> tells us that, “The completeness of an extractables assessment can only be judged against the overall goals of the assessment.” By defining your risks up front and developing thoughtful test plans, you can ensure that your decisions are both data-driven and patient-focused.
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.
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
In view of patient safety and product quality, extractables and leachables assessments of pharmaceutical packaging and delivery systems have become an integral part of both development and regulatory submissions. Two crucial USP guidance chapters, USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems” have been published to guide pharmaceutical companies on the practical and technical considerations required for extractables and leachables assessment programs.
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663><sup>1</sup> and <1664><sup>2</sup>. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
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.
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