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The FDA states: 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.* 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.
Working groups like Product Quality Research Institute (PQRI) and guidance chapters like USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems provide direction. For small molecule drug products, manufacturers must understand these guidances and determine how to apply them for extractables and leachables evaluations of individual drug products.
With expertise in both materials science, and extractables and leachables evaluations for pharmaceutical packaging components and delivery devices, West Analytical Services has an established approach for executing extractables and leachables evaluations for individual drug products. This approach comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing. Through knowledge and experience, West subject matter experts partner with customers to reduce the risk to their drug product by designing and performing the studies that identify leachables from the primary packaging components.
Industry best practices ask drug product manufacturers to gain data on extractables first, then evaluate those extractables via a risk assessment to identify target leachables, and lastly develop and validate methods at appropriate levels to quantitate leachables levels in the drug product. The process of performing these studies can be time intensive. This is a challenge given the nature of market demands for drug product manufacturers, who need to move quickly to help ensure that drugs reach the market safely and efficiently. To meet this need, West’s AccelTRA® component program is designed to deliver stoppers and plungers to generics manufacturers with quality, speed, and simplicity. As part of this program, West customers have access to the AccelTRA Extractables Profile, which allows them to perform an assessment of extractables from the 4031 component..
In addition to understanding the guidances mentioned above, the industry faces challenges of quickly getting a therapeutic or life-saving drugs to market, and the potential lack of knowledge and resources needed to meet regulatory expectations. To enhance the AccelTRA component program further to address these challenges, West Analytical Services has developed 4031 Ready Methods. The 4031 Ready Methods are partially validated leachables methods for extractable compounds. These methods were developed using drug product solutions such as water-based solutions, common solvent solutions such as buffer solutions, and benzyl alcohol. These drug product solutions were used as models based on an understanding of their typical use in small molecule injectable drug products. Customers can perform a gap assessment with the 4031 Extractables Profile. If additional extractables testing is not needed, they can move directly to next steps: (a) risk assessment for the toxicological evaluation; (b) identification of target extractables for leachables and the minimum quantitation limit (MQL); and (c) determination of feasibility of the chosen extractables in their small molecule drug product and drug specific validation. This can help reduce the overall testing time. After the completed validation work, the end result is specific customer-based leachables methods that then can be used for stability testing.
West Analytical Services is also able support customers with two additional services:
The goal of both is to aid in the customer’s assessment of the extractables data in order to, ultimately, pick the appropriate 4031 Ready methods as well as target levels.
West Analytical Services has been performing extractables and leachables evaluations for over 20 years, providing a holistic approach for customers’ container closure system, device, or combination product. We deliver tailored extractables and leachables solutions based on the stage of development of the product to address the challenges faced by the customer and the industry. By integrating our knowledge and expertise of materials, components, packaging, and analytical testing, West is able to offer a more comprehensive approach and timely delivery of generics manufacturers' packaging and regulatory needs through the AccelTRA component program with the 4031 Ready Methods. Contact us for more information.
AccelTRA and E2L are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
* Code of Federal Regulations Title 21. Section 211.94. Drug product containers and closures (a) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=211.94
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
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 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 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.
Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.
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?”