FDA strengthens and modernizes inspections for sterile injectable drugs

Home/Policies & Legislation | Posted 23/11/2018 post-comment0 Post your comment

On 9 November 2018, the US Food and Drug Administration (FDA) announced that it was taking new steps to modernize its inspections programme with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.

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The agency has developed a New Inspection Protocol Project (NIPP), which uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of findings.

The first phase of NIPP was aimed at developing a protocol that could be used during aseptic processing surveillance and pre-approval inspections. This, according to FDA, was a logical starting place because of the significant impacts on patient safety if the quality of sterile injection drugs are compromised, as well as because of quality issues that have led to shortages. Most drug shortages involve generic, sterile injectables; in 2011, these accounted for 73% of all reported drug shortages [1].

‘With better and more consistent oversight of these manufacturing facilities, we hope to be able to spot problems earlier and implement mitigation steps that can avert dangerous drug shortages’, said FDA Commissioner Scott Gottlieb.

FDA conducted multiple pilots of the NIPP protocols to ensure that they would be consistent with current programme objectives and integrate into the way investigators conduct inspections. Each new protocol version underwent extensive revision and refinement based on feedback received from investigators, compliance officers and reviewers.

These aseptic processing drug inspection protocols for sterile drugs are the first of what FDA plans to be a series of valuable new inspection protocols covering all dosage forms. The agency plans to have more protocols ready for full implementation within the next two years.

In Australia, also in response to drug shortages, the Therapeutic Goods Administration (TGA) has updated its plan for mandatory drug shortage reporting based on public comments in response to an April 2018 request.

Related article
Generic injectable prices stay high even after shortages resolved

1. GaBI Online - Generics and Biosimilars Initiative. Drug shortages linked to quality control costs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-linked-to-quality-control-costs

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Source: TGA, US FDA

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