US inspection protocols offer a more transparent, risk-based approach, says Recipharm

By Flora Southey contact

- Last updated on GMT

(Image: Getty/tumsasedgars)
(Image: Getty/tumsasedgars)

Related tags: Fda, Inspection, Sterile Injectables

The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.

Earlier this month, the US Food and Drug Administration (FDA) announced plans to ‘strengthen and modernise’ auditing and reporting procedures for sterile injectables manufacturing.

The New Inspection Protocol Project​ (NIPP) facilitates the collection of information during the inspection in a standardised format, and helps to generate an establishment inspection report (EIR) afterward, an FDA spokesperson explained.

“The electronic inspection protocols enable semi-automated generation of EIRs for pre-approval and surveillance inspections, for aseptic manufacturing, and are expected to save investigators time in compiling data, which will also help with efficient analysis of the inspection.

“The structured protocols also facilitate consistent coverage of critical elements of the inspection,” ​the spokesperson continued.

In addition, the NIPP will provide ‘data-rich reports’ that can be used by the FDA to adapt inspections in response to the seriousness, or risk, of GMP violations. “The structured protocol also makes it easier to analyse data to find anomalies and inform decisions that can reduce risk to patients,” ​according to the FDA.

Initial focus

The NIPP targets sterile drug manufacturing – an area which has experienced GMP deficiencies, and as a result, prompted insufficient medicine supply.

Earlier this decade, for example, major drug shortages​ were experienced in the US following the closure of Ben Venue Laboratories – the world’s largest sterile injectables manufacturer – in Ohio, US. Long-term quality deficiencies were responsible for the closure.

“At this point, the FDA is focused on increasing the efficiency of reporting and gathering more data regarding the state of quality in drug manufacturing. 

“Collecting and analysing this data will give the FDA a better understanding of the state of quality in drug manufacturing facilities and aid in application and other regulatory decisions,” ​we were told.

Once a sufficient amount of data has been collected from the protocols, the agency will evaluate other potential uses – such as incorporation into the site-selection model, the spokesperson continued.

Recipharm responds

Swedish contract development and manufacturing organisation (CDMO), Recipharm, has voiced its support of NIPP, which director of quality management, Roberta Vigna, described as “an improvement process step, with the final goal [being] to prioritise inspections using a risk-based site selection model with a better focus on real risk on patient health.”

The NIPP offers industry “a more transparent, objective, risk based approach”, ​she added.

“[The project is] focused on verifying a sustainable system for continual improvement of product and process quality implemented at the manufacturing site instead of looking for basic GMP compliance.”

Vigna highlighted the need to continue facilitating a risk-based approach, in order to further prevent against sterile drug product shortages. She also stressed the importance of ‘culture’ within the industry:  “For modernisation and progress to be possible in the pharma industry, we must develop a culture where change can occur more easily and efficiently,” ​we were told.

Related topics: Regulatory & Safety, QA/QC, Regulations

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