FDA’s Good Importer Practices Guidance: What You Need to Know?

• By: Staff Editor
• Date: June 26, 2017
• Source: http://www.fda.gov

FDA’s Good Importer Practices Guidance: What You Need to Know?

The U.S. FDA, among other several government agencies such as USDA, EPA, U.S. Department of Homeland Security, Customs and Border Protection etc., published a draft guidance on Good Importer Practices (GIP) in 2009. This draft guidance offers general suggestions to the importers on procedures and practices they should follow to ensure that products they import are in compliance with the U.S. safety and security requirements.

The guidance document further provides recommendations on how importers can develop effective measures to prevent the importation of possibly hazardous and unsafe products. As quoted in this guidance, “This draft guidance document would not establish legally enforceable rights or responsibilities. Instead, this guidance document, when finalized, would describe the current thinking of US federal departments and agencies on a topic, and readers should view it only as recommendations, unless the document cites specific regulatory or statutory requirements.”

Good Importer Practices- Principles

These GIP are chiefly categorized into following four guiding principles:

1. Establishing a Product Safety Management Program: The safety program established by the importer should have following features: process to analyze, evaluate, and control the risks in product life cycle; formal quality assurance program; trained, knowledgeable and experienced personnel; and maintaining SOPs and records.
2. Knowing the Product and Applicable U.S. Requirements: Identify the details of the products an organization is importing and the applicable regulatory requirements; regulatory compliance history of the firms that are involved in the design, manufacture and distribution of those products; and regulatory framework of the countries of origin.
3. Verifying Compliance with U.S. Regulations throughout the Supply Chain and Product Life Cycle: vendor/supplier qualification; develop appropriate controls, monitor and verify products compliance during and after distribution to U.S. customers.
4. Taking Corrective and Preventive Action (CAPA) When the Imported Product or Firm Is Not Compliant with U.S. Requirements: establish procedures for developing CAPA; root cause analysis; and stop conducting business with the non-compliant firm.

The guidance appendix covers the respective Agency’s roles and responsibilities for the range of products that are being imported into the US.