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CMC and Manufacturing Compliance

ELC Group helps leading pharma company pass FDA inspection with flying colours

A leading pharmaceutical company turned to regulatory experts elc group to ensure it had successfully addressed FDA concerns as it prepared to face an important FDA re-inspection visit.

The Challenge

“As impartial observers, elc group showed us how our operation held up in reality – where we were at risk of failure – and gave us clarity on where we needed to focus resources and how.”

Ensure new compliance levels met with rigorous FDA standards.

After the issue of an FDA warning letter, following a GMP inspection at one of its plants in South Asia which manufactures generic drugs for the US market, this leading pharmaceutical company underwent months of remediation to address the observations and concerns identified by the FDA.

While the warning letter did not restrict production or shipment of the company’s products, unless it could demonstrate it had corrected outstanding issues to the FDA’s satisfaction there was a risk the FDA may withhold approval of pending drug applications. Even worse, the FDA could potentially withhold permission to export products manufactured at the facility into the US and place the site under extended regulatory scrutiny.

With an FDA return visit just weeks away, the company needed to be confident its manufacturing site would pass the inspection without fail.

With just eight weeks to go, the company turned to elc group to undertake an independent inspection, eliminate any identified deficiencies, and prepare its people for the all-important FDA re-inspection.

The Solution

Undergoing an independent assessment to ensure compliance gaps could be identified and addressed prior to the FDA re-inspection visit

The pharmaceutical company wanted to be confident it had successfully addressed each and every concern identified by the FDA and was now in full conformance with the FDA’s requirements.

As regulatory experts, elc group would provide a detailed critical assessment of the revised compliance framework that had been put in place at the manufacturing site. Its team of auditors, which included former FDA investigators and experts with over 30 years’ industry experience in developing and implementing remediation plans, would provide an impartial review of both people and processes.

Employing the Quality System Inspection Technique (QSIT) used by the FDA, the inspection team performed a detailed ‘mock’ FDA audit at the plant, putting employees through realistic inspection-style interviews. At the close of the visit, the elc team detailed a list of identified gaps - prioritised by risk – developed a remediation plan, and supported the company to resolve these issues before the scheduled FDA re-inspection visit.

As part of this remediation process, in the weeks leading up to the FDA re-inspection the elc team delivered high impact training for employees so they were well prepared for the questions they were likely to face from FDA inspectors on the day.

The Result

The company passed the FDA inspection, its warning letter status was removed and several new products received approvals

“We gained the confidence of knowing we were well prepared to undergo the FDA re-inspection. Failure would have been costly – putting us at risk of extended regulatory scrutiny, and the potential withholding of important drug approvals.”

The professional expertise and impartial viewpoint of the elc group inspection team ensured the company was able to experience a ‘real-life’ FDA inspection which thoroughly tested its current level of conformance.

Thanks to the elc team, deficiencies were uncovered well ahead of the FDA re-inspection visit, and a remediation plan was developed to resolve these in the required timeframe. The company also gained an independent perspective on which issues posed the greatest risk, and with elc’s help was able to address these in order of priority.

In addition the elc team supported employees as they prepared for the FDA inspection. Alongside identifying the typical line of questioning employees would face - and how to respond - the team delivered training on GMP compliance guidelines.

The benefits of a GMP audit solution from elc group include:

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