More systems training needed to help inspectors spot data falsification say PIC/S experts

By Gareth Macdonald

- Last updated on GMT

iStock/ credit Olivier Le Moal
iStock/ credit Olivier Le Moal

Related tags Food and drug administration

Data falsification at API facilities is getting harder to spot say regulators who have called for more systems training and international collaboration.

Regulators who attended the PIC/S Expert Circle on APIs in October said spotting faked or manipulated records requires expert knowledge of increasingly complex systems.

Attendee Carmelo Rosa, Director of the US FDA’s Division International Drug Quality, told us “inspectors need to feel comfortable with the systems used, and have an understanding of the things a person can do in the electronic world in an attempt to hide, delete, substitute, or modify results​.”

He cited falsification of batch records and the practice of recording manufacturing activities before they occur as common data integrity issues that inspectors encounter.

Rosa also suggested that because they know spotting such deficiencies takes time, some API manufacturers even “try to refocus the scope of the inspection, delay or deny access to critical areas, which makes it difficult for the inspections​.”

To combat this some PIC/S members, including the US Food and Drug Administration (FDA), have the power to say a drug is adulterated if an inspection is delayed, or if inspectors are denied access to records or the site. 

Delegates at the meeting, which was hosted by the European Directorate for the Quality of Medicines & HealthCare (EDQM) in Strasbourg, France, also stressed the importance of regular technical training for inspectors.

International collaboration

Collaboration was another major discussion point at the meeting, where national agencies were urged to share more information with counterparts.

Rosa told us while regional regulators are working together and sharing information at an “unprecedented level​,” more needs to be done.

More joint inspections are needed to continue harmonizing our inspection approaches and outcomes​” he said, adding that “the more we interact, the more close we will get to relying on each other’s inspection.”


Membership of PIC/S provides a basic set of good manufacturing practices (GMP) guides for active pharmaceutical (API) production and guides for the manufacture of sterile medicinal products.

The organisation also provides member organisations with seminars and training sessions relative to APIs, computerized systems, human blood tissues, quality risk management and good distribution practices.

PIC/S is also used by regulators to keep track of drugmakers’ compliance with manufacturing standards.

The advantages of such collaboration were aslo stressed by MHLW director Haruo Akagawa at a conference in Japan earlier this year.

He told delegates at CPhI Japan​ the membership of PIC/S - granted to the regulator  and sister organisation the Pharmaceuticals and Medical Devices Agency (PDMA) in July 2014​ "the purpose of PIC/S is to pursue and strengthen the cooperation established, to provide the framework for the sharing of information and experience on a voluntary basis.

I profoundly hope that [drug] candidates and innovative products will be delivered to patients as soon as possible, not only from Japan but also for the whole world with assured international quality levels and they will help patients suffering from diseases​” he said.

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