Should Environmental Standards be a Part of GMP Inspections?

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Representatives from the US FDA, EMA, WHO and the pharma industry debated over the possible inclusion of environmental impact in future good manufacturing practice (GMP) inspections of drug production sites and the need for a new type of relationship between companies and regulators.

We need more information and data to decide who will be responsible for monitoring waste management.

Dimitrios Catsoulacos, WHO

During a panel discussion on sustainability organized by the International Society of Pharmaceutical Engineers (ISPE) in Madrid on April 26, the moderator asked if a pharma production site’s environmental impact should be included in future GMP inspections, thus requiring companies to comply with waste management standards in order to get approved or continue operating.

Speaking at the panel were representatives from the World Health Organization (WHO), the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and ISPE.

The representative from the WHO, inspector Dimitrios Catsoulacos, first tackled the question. He contended that the idea has been discussed but several factors make it unviable at the moment. Catsoulacos pointed to a WHO recent survey which found that in most countries around the world the agencies in charge of regulating pharmaceuticals are not responsible for environmental issues such as waste management but, rather, the task falls to separate environmental agencies.

He revealed that a published document from the UN agency indicates that inspectors from the WHO, when visiting manufacturing sites where antibiotics are produced, will be checking waste management systems in place and issue recommendations to member states.

However, he said, the WHO did not include that in its GMP guidelines “because the expert committee felt that it is not yet time to include them. We need more information and data to decide who will be responsible for monitoring waste management.”

The immediate reply came from the representative of the FDA Carmelo Rosa, director of the agency’s Division of Drug Quality, who argued that it is not necessary to wait for the United Nations to resolve some of the issues that the American agency continues to find when inspecting pharma plants.

You go into a facility and see repeated issues with contamination within the water systems …

Carmelo Rosa, Director of the FDA’s Division of Drug Quality

“There are challenges in the area of quality sustainability. You go into a facility and see repeated issues with contamination within the water systems, for example. Those are things that we already have regulations for, including how to investigate and address them. There is a lot that can be done now; we do not have to wait for the United Nations to resolve some of the issues we are seeing.”

The panel moderator, who consults for the pharma industry, told Mr. Rosa that many of his clients are fearful of making any changes because of what regulators like the FDA might “find.”

The FDA rep replied that companies should take a proactive approach and not wait for regulators to find issues. “We often find ourselves serving as a quality unit for companies,” Mr. Rosa said. “The problem, I think, is that a lot of the approaches to regulators come after the regulators find problems for them, rather than being proactive, rather than having a close examination of the lifecycle of their product.”

“We go into a facility and ask a simple question: why is this probe here? And we can get an answer.”

The lead scientific officer of the EMA, Brendan Cuddy, took the opportunity to agree with his FDA counterpart. “I think Carmelo really touched on a key point which is communication. For many of the initiatives we have discussed to be successful we rely on clear, open and transparent communication with the industry. It is absolutely central to everything we are trying to achieve,” he said.

A few minutes earlier, Cuddy had relayed the importance of the pharma industry meeting sustainability goals, saying that waste management should be emphasized not only because of its impact to the environment, but also due to its link to the issue of anti-microbial resistance.

We need to have appropriate reference standards… but I don’t think that they are available at the moment.

Nathalie Moll, Director General, EFPIA

“Sustainability is an important topic within the EU. Whether we talk about financial services, trade policy or pharmaceuticals, sustainability is key… In terms of adopting [within the EU legal framework] any provisions around manufacturing or supply to ensure environmental sustainability, I can say that it is currently under discussion.”

Finally, the head of EFPIA, Nathalie Moll, picked up on Cuddy’s call to action saying that the industry has been been looking at improving its scientific understanding in order to detect trace amounts of pharmaceuticals, understand the impact they have and prioritize the ones that pose a larger risk to the environment.

“It is something that we work on continuously, not just as the innovative industry, but together with our generic and over-the-counter colleagues… Hopefully, the dialogue is there with [the regulators] to review that information so that you do not just discover but we bring it to you,” Moll said.

Regarding the question of GMP inspections including sustainability measures, the EFPIA director general put on a set of conditions. “I want to bring some prerequisites from our side. The change should be announced because we would need to prepare. We need to have appropriate reference standards… but I don’t think that they are available at the moment.”


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