EGA calls for better API quality measures

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalised supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

Speaking at the EDQM’s Quality of Medicines in a Globalized World: Dreams and Reality international conference last week, Suzette Kox, Senior Director of Scientific Affairs at the EGA, explained in a statement that pharma manufacturers must exercise care when selecting API suppliers, and should monitor them carefully to ensure that only GMP-compliant APIs are used. She recommended both industry and regulatory authorities apply a common risk-based prioritization to API manufacturers and suppliers, as well as to increase focus on API audit programmes and reports during EU inspections.

“Since the relationship with API manufacturers is an essential part of maintaining the integrity of the supply chain, business only with certified partners provides the guarantee of uninterrupted and timely exchanges of information and continuous quality assurance,” said Kox.

To overcome the issue of limited resources, the EGA also suggested the creation of a formal EU Inspection Group to optimize an existing network of national inspectors and to free up more inspection capability. Kox also explained the importance of industry access to inspection information such as inspection outcomes, GxP compliance and operator licenses, which can support risk assessment and audit prioritisation. “Access to a schedule of upcoming routine inspections by EU health authorities would allow optimisation of audit planning,” Kox also added.

Regarding international cooperation, the EGA has recommended streamlining inspections at a global level by building on a number of existing platforms and agreements, such as leveraging the experience of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme to assess ‘equivalence of standards’ between countries. Additionally, the EGA recommended developing bilateral agreements to facilitate exchange of information, training, common understanding and confidence building with key API exporting countries.

In the long term, the EGA also hopes the industry can work towards a long-term global inspection framework.

“The industry is dreaming of truly globally harmonized standards for pharmaceutical products and APIs, including pharmacopeias and why not a harmonized regulatory system, with harmonized registration requirements and assessments, and mutual recognition of approvals and inspections,” said Kox. “This EDQM international conference contributes to setting the scene and paving the road in that direction.”

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