FDA looks to NIPP inconsistent inspections in the bud

Dan Stanton, Managing editor

November 14, 2018

2 Min Read
FDA looks to NIPP inconsistent inspections in the bud
Image: iStock/SvetaZi

The New Inspection Protocol Project (NIPP) intends to increase the speed and efficiency of sterile injectable facility inspections through the semi-automated generation of establishment inspection reports (EIRs).

In efforts to modernize inspections program, the US Food and Drug Administration (FDA) has developed a new protocol to assess, record and report the data from surveillance and pre-approval inspections for sterile drug products.

“The New Inspection Protocol Project (NIPP) is focused on modernizing our inspection approach and enabling continual improvement of our programs,” a spokesperson from the regulator told BioProcess Insider. “The protocols will help improve inspection coverage, as well as increase efficiency in data collection, reporting, and analysis.”


Image: iStock/SvetaZi

The protocols will facilitate the collection of data during the inspection and generating an establishment inspection report afterward, we were told.

“Semi-automated generation of EIRs for pre-approval and surveillance aseptic manufacturing inspections is expected to save investigators time in compiling data and will also help with efficient analysis of the inspection.”

According to the Agency, such protocols will help fulfil the need to efficiently collect and analyze information gathered during inspections to give a better and timelier insight on the state of quality in drug manufacturing facilities, while promoting the relevance of this information to its regulatory decisions.

Pilot program

Multiple pilots of the NIPP were undertaken by the FDA to ensure that they would be consistent with current program objectives and integrate into the way investigators conduct inspections.

“The surveillance protocol and pre-approval inspection protocol for aseptic processing operations were each piloted three times,” the spokesperson said, in order to refine and revise them.

According to the FDA, the protocols for sterile drugs will be the first of a series of new inspection protocols covering all dosage forms.

“As we integrate learnings from these pilots in our field activities, our goal is to have them ready for full implementation within the next two years. These modern tools are a key part of our efforts to protect the health and safety of US patients.”

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.

Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.

From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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