FDA will revise cGMP guidelines to strengthen management supply chain

Brian Hasselbalch revealed plans to revise the cGMP guidelines. In terms of production quality management, in 2010, the FDA's priority is to increase understanding of the supply chain, mainly to fully understand the original manufacturer and follow-up procedures, and strengthen the audit of the original manufacturer, in addition to Check each packaging container for each shipment; strictly implement the notification system for contaminated goods to the FDA, and use the unique component identification as the safety requirement for the intended use or inclusion in the approval application.

The content to be improved by cGMP also includes some new requirements: such as establishing a “management responsibility system” to ensure consistency with cGMP, including resource provision and periodic auditing systems; and requiring self-examination and response capabilities.

Another issue of concern is outsourcing and contract manufacturing. The regulatory framework for outsourcing has a different description in the US Food and Drug Law. However, in recent years, problems arising from contracts or commissioned production have increased year by year, and the warning letter issued by the FDA has also increased significantly. Brian Hasselbalch stressed that the main problem of contract production is the division of responsibility, and contract manufacturers have the responsibility to produce cGMP-compliant products. The contract manufacturer company employed shall bear the specific responsibility in the relevant legal provisions, and the private OEM distributor shall also be responsible according to the law. An important part of the quality agreements signed between the two parties is that the pharmaceutical manufacturers are no longer only part of the process of supervising themselves. They also need to cover the following important aspects: providing the contract production address, plant and equipment/production lines and services/materials. Proof; contract-produced drugs and instructions for their use, including all specifications; periodic cGMP audit reports and contract details are required.