Mandatory overseas API inspections needed; ITRE

The European Commission (EC) excluded overseas mandatory inspections from the draft because they would be too expensive. However, this was based on a figure that Chris Oldenhof, president of the Active Pharmaceutical Ingredients Committee (APIC), described as “entirely absurd​”.

Industry groups such as APIC feel that mandatory inspections are a vital aspect of keeping falsified products out of the European Union and the Committee on Industry, Research and Energy (ITRE) appears to share this view.

ITRE is one of three European Parliamentary Committees involved in amending the draft directive. In its recently published proposed amendments to the directive ITRE stated that repeated mandatory, and if necessary unannounced, inspections are needed to “ensure that public health is properly protected​”.

This amendment and others in the document are in line with the thinking of the European Fine Chemicals Group (EFCG), Oldenhof told Outsourcing-Pharma. He added that implementing mandatory inspections will require a “reconsideration of priorities​”.

Oldenhof advocates moving towards a risk-based inspection system. This would reduce the intensity of inspections of facilities that have excellent compliance records to allow resources to be reallocated to sites with potentially harmful production practices.

By making this shift, implementing inspection fees and increasing cooperation and resource sharing between international agencies Oldenhof believes mandatory inspections are economically viable.

Amalia Sartori, rapporteur of ITRE, added to Outsourcing-Pharma that she understands that 40 inspectors at the European Union (EU) level would be needed for the inspection programme.

Traders and brokers​

The committee hopes to support mandatory inspections with stronger laws covering traders and brokers in the EU. It states that traders and brokers “should be clearly and unambiguously defined, as should their responsibilities​”.

Furthermore, ITRE calls for traders and brokers to have a valid license and “be subject to a rigorous accreditation, verification and good-practice system​”. By implementing these measures ITRE hopes to regulate elements that have contributed to the complexity of the supply chain.

However, neither the mandatory inspection programme nor the verification of EU traders directly tackles the problem of unapproved overseas API plants. Products from these ‘shadow factories’ can potentially enter the legal supply chain through the complex network of overseas traders.

It is unfeasible to inspect all these sites but Oldenhof believes that by educating inspectors about fraudulent supply chain activities they will be able to detect falsified API’s at approved plants.

To help with this education the EFCG has prepared a list of tips and tricks for detecting fraud which it has presented to inspectorates. By using these lessons Oldenhof believes inspectors have a good chance of detecting fraud and stopping falsified APIs entering the legitimate supply chain.