Regulators Should Rely on Peers’ GMP Audits to Cut Inspection Burden

Biopharma is a global industry with drug firms routinely supplying medicines to multiple markets from the same manufacturing plant. But while globalization has helped expand revenues, it has also increased the number of GMP inspections developers undergo.

The average biopharmaceutical production facility has 2.68 good manufacturing practices (GMP) inspections a year, with auditors spending up to nine days on site per visit, according to recent analysis.

Preparing for an inspection typically involves GAP analysis to determine how current practices measure up to regulations, followed by corrective actions.

Companies also need to ensure they have the correct documentation for all operations. How long these preparatory steps take varies for each company. However, according to the U.S. Center for Professional Innovation and Education, getting set up for an audit can take anywhere from six months to a year.

Down with duplication

But drug companies should not have to undergo multiple GMP visits, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which says regulators can cut the number they carry out through collaboration.

Sérgio Cavalheiro Filho, IFPMA’s regulatory affairs manager, tells GEN, “The most pressing compliance challenge relating to good manufacturing practice today is the inefficiency created by duplicative inspections.

“In an increasingly complex and globalized manufacturing landscape, it is critical that we look to reduce unnecessary duplication through greater inspection reliance amongst those national regulatory agencies that belong to the Pharmaceutical Inspection Co-operation Scheme.”

For the uninitiated, the Pharmaceutical Inspection Co-operation Scheme is an informal arrangement between regulators focused on GMP. Its key aims are to harmonize inspections and promote information sharing between regulators.

It also aims to foster trust between regulatory agencies, with the idea being to encourage them to rely on GMP inspections carried out by fellow regulators rather than re-auditing sites themselves each time certification is sought.

“Greater inspection reliance would allow both regulators and companies to focus resources where they matter most: patient safety and product development,” Filho says.

IFPMA made the case for greater inspection reliance in a position paper, arguing that while pilot mutual recognition efforts have shown promise, regulators have yet to fully embrace the approach.

Filho tells GEN, “Regulators have made meaningful progress on GMP harmonization through frameworks such as PIC/S and ICH, but more consistent use of inspection reliance is needed to translate alignment on paper into real efficiency.”

Part of the problem is that advanced modalities, such as mAbs and cell and gene therapies, are often perceived as being higher risk, which means, despite the various mutual recognition agreements, regulators still tend to carry out their own inspections.

However, in such cases, trusting others’ audits is a more efficient option, according to Filho, who says, “Relying on trusted regulatory partners where appropriate is a well‑tested and effective strategy that enables regulators to focus on higher‑risk activities. And, any steps to reduce the incidence of the GMP audits they face would be welcomed by biopharma, Filho adds.

“Industry supports moving from pilots to routine reliance, underpinned by sound legal and data‑sharing frameworks. GMP challenges are also increasingly addressed through collaboration between manufacturers and technology suppliers, and through digitalization, automation, and AI‑enabled tools that strengthen monitoring and quality oversight within robust quality systems,” he says.

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