GMP (Good Manufacturing Practices) is a quality assurance system for a broad range of processes and products. In the life science industry for instance, these range from infusion solutions, pain medications and natural remedies to prosthetic legs, pacemakers and toothbrushes. Achieving safety for the end consumer through uniform quality standards is a challenging task – but precisely formulating the rules and regulations has proven impossible. Degrees of freedom must be allowed for specific adaptation to a range of variants, using should, could and also working with omissions. Finding the right interpretation for the respective product or process with the correct implementation in compliance with official requirements is the key. This is among the strengths of gempex. Here the focus in designing GMP concepts remains on the primary objective – consumer protection!
Starting from Pole Position – Benefit from Experience
Even if one has nothing at all, there is no need to start at zero. At least one has the certainty that others have already established GMP concepts and accumulated experiences. Why not fall back on best practices and put this knowledge to use? With the realisation of more than 200 projects per year, gempex operates on the basis of broad practical experience with requirements and solutions. It therefore gives its customers a head start, putting them in pole position.
Individualised Standards – a Contradiction?
Putting best practices and experience to use also means using templates. Yet templates can be dangerous. Copy, paste, done? No. Problems become apparent, at the latest during the next inspection. Templates are tools and gempex has hundreds of them today. These tools are used to design specifics, the individual process, on the basis of standards. They are useful as checklists, as a good starting point to design the best possible process for the user.
Do You Really Have Nothing, or Are You Simply Not Aware of It?
Experience has revealed few cases where there is actually nothing. All companies have a more or less developed quality system today, processes are defined and risks are identified. The critical points are familiar, one knows what indicates when things get critical and how to address the situation, perhaps this is also described somewhere. That is why gempex almost always starts projects off with a gap analysis or by conducting a workshop to determine: What exists and can be used? What is missing and must be developed? Only after this analysis is the roadmap for the next steps established. Often the customer is surprised at how little needs to be done to establish GMP. Thanks to common sense, the goal may not be all that far away.
Step by Step with Pragmatism
Introducing GMP concepts means verifying the suitability of “hardware”, challenging the performance of technologies, establishing new processes and adapting existing ones. It also means training people, instructing them in new processes, raising awareness and gaining their support for something new! This is essential for a functioning GMP system. It succeeds with practical concepts. All required formalism notwithstanding, gempex places special emphasis on this and stands for pragmatic, goal-oriented solutions. The implementation and establishment of GMP concepts is realised step by step, well planned and clearly comprehensible for the stakeholders: gap analysis, adaptation of what is already in place, new development based on what is proven, “hardware and software” check, training and raising employee awareness.
- implementation of best practices based on broad practical experience
- access to numerous samples and templates used judiciously by experts
- minimisation of effort by using what already exists in a company
- pragmatic and practical solutions
- quality planned step by step