The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
The document, entitled Good Importer Practice and available to review here [http://www.fda.gov/oc/guidance/goodimportpractice.html], is designed to “prevent or detect potential problems at critical points along the product’s life cycle to avoid placing the US consumer at risk,” according to the agency.
While not specifically addressing the pharmaceutical sector, the draft guidance contains a number of key principles that indicate the FDA’s overall thinking in this area.
For example, the guidance indicates that importers should know the foreign firms that produce the products they purchase, any other firms with which they do business and through which such products pass (e.g., consolidators, trading companies and distributors).
Importers should also understand the products that they import and the vulnerabilities associated with these products, as well as the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards.
The guiding principles behind the document are that importers should develop a safety management programme, with defined job functions, responsibilities and accountability.
The FDA expects importers to be aware of the regulatory framework for the imported product, and make sure that they remain compliant with the requirements “throughout the supply chain and product life cycle.”
The document stands very much alongside the agency’s recently-released draft guidance on standards for securing the drug supply chain, which recommended standardised numerical identification for prescription drug packages.
The import practice guide its alongside another just-released document – a draft guidance on submission of laboratory packages by accredited laboratories – which is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements.
The guidance advises importers how to use accredited labs and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA.