An extractables/leachables strategy facilitated by collaboration between drug product vendors and plastic material/system suppliers.

摘要

Leaching of plastic materials, packaging, or containment systems by finished drug products and/or their related solutions can happen when contact occurs between such materials, systems, and products. While the drug product vendor has the regulatory/legal responsibility to demonstrate that such leaching does not affect the safety, efficacy, and/or compliance of the finished drug product, the plastic's supplier can facilitate that demonstration by providing the drug product vendor with appropriate and relevant information. Although it is a reasonable expectation that suppliers would possess and share such facilitating information, it is not reasonable for vendors to expect suppliers to (1) reveal confidential information without appropriate safeguards and (2) possess information specific to the vendor's finished drug product. Any potential conflict between the vendor's desire for information and the supplier's willingness to either generate or supply such information can be mitigated if the roles and responsibilities of these two stakeholders are established up front. The vendor of the finished drug product is responsible for supplying regulators with a full and complete leachables assessment for its finished drug product. To facilitate (but not take the place of) the vendor's leachables assessment, suppliers of the materials, components, or systems can provide the vendor with a full and complete extractables assessment for their material/system. The vendor and supplier share the responsibility for reconciling or correlating the extractables and leachables data. While this document establishes the components of a full and complete extractables assessment, specifying the detailed process by which a full and complete extractables assessment is performed is beyond its scope.