We at GMP-Verlag call it greenGMP. Because the GMP requirements can be interpreted in many ways. When we think of the sustainability goals, we have to question existing interpretations, find new interpretations and implement them consistently.
greenGMP is therefore not a new regulatory requirement, but a plea for common sense, telling us that "business as usual" is not an option.
For:
It is up to us and quality management has a key position in this.
A process cannot be changed without approval. The people in quality management play an important role in this. They are the ones who give this approval and release.
At the same time, they can also suggest changes or modifications to processes. This means that quality teams can significantly influence measures to reduce CO2 and energy consumption. The self-image of the people involved plays an important role. Do they want to support changes or prevent them?
The question about the influence of the quality teams can therefore be easily answered: In my opinion, they sit in a key position that decides whether CO2 targets are achieved or not in the company.
Some companies have set themselves the goal of becoming CO2 neutral in their own production facilities by 2025. There is not much time left until 2025 – if you include implementation, it is important to act quickly and consistently.
It would be disastrous if meaningful process changes were senselessly blocked.
Quality management could also actively support the achievement of sustainability goals and see this as a new field of activity. Quality could become the gatekeeper of sustainability!
Why? Many processes that are very energy-intensive are predefined by GMP requirements or rather their currently common interpretations. If one follows a risk-based approach and includes sustainability criteria in the risks, it is already possible to change the parameters of various processes today.
Of course, it is important not to jeopardise product quality. It is also not at stake with many technical solutions. Rather, the question arises as to the willingness to defend a risk-based and scientifically justified OTHER interpretation in inspections and audits.
From my project experience over the last 30 years, I see a need for action here! It may also take a little courage to defend new approaches. If such approaches are also supported by publications, associations and communities of interest, positive results could quickly change the industry.
The tendency to leave things as they are because they have always been that way should be mothballed. Therefore, I recommend rethinking the role of quality management. Quality staff should be involved in relevant projects at an early stage. And why not establish sustainability goals, e.g. energy savings, as performance indicators or KPIs for quality teams?
This article is a shortened and translated excerpt from the 32nd episode of our GMP & TEA webcast in German language.
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