European Generic Medicines Association Addresses Supply-Chain Quality Issues, Recommends Global Inspection Framework

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

Speaking at the European Directorate for the Quality of Medicine’s (EDQM) Quality of Medicines in a Globalized World: Dreams and Reality international conference last week, Suzette Kox, senior director of scientific affairs at EGA, explained in a statement that pharmaceutical manufacturers must exercise care when selecting API suppliers, and should monitor them to ensure that only GMP-compliant APIs are used. She recommended that both industry and regulatory authorities apply a risk-based approach to the selection of API manufacturers and suppliers. The approach may also increase the focus on API audit programs and reports that take place on European Union 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 challenge of limited resources, EGA 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.

“The online access by the industry to most information on inspection outcomes as foreseen today, GxP compliance and operator licenses (e.g., importers) is expected to constitute an invaluable tool for industry to support their risk assessment and audit prioritization,” said Kox. “Access to a schedule of upcoming routine inspections by EU health authorities would allow optimization of audit planning.”

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

In the long term, EGA said it hopes the industry can work toward a long-term global inspection framework. “The industry is dreaming of truly globally harmonized standards for pharmaceutical products and APIs, including pharmacopoeias 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.”