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Röchling Medical Quality Systems
  • Medical
  • Quality Systems
  • Good Manufacturing Practice
  • Good Manufacturing Practice (GMP-Plus)

    Röchling Medical has developed “GMP-Plus” in order to offer our customers even more service and security, above and beyond GMP guidelines. GMP-Plus is a protected in-house brand that takes cleanliness to a whole new level, for even more added value!

    GMP stands for Good Manufacturing Practice for medicinal products, and represents a set of national and international rules that govern, among other things, requirements for hygiene, premises, equipment, documentation and inspections. Quality assurance plays a central role in the manufacture of pharmaceutical products, since deviations in quality can have a direct impact on user health. For this reason, our employees undergo regular training regarding GMP guidelines.

    Although Röchling Medical’s manufacturing processes already adhere strictly to these regulations, we still want to offer our customers more than this already-high level of quality. This is why we developed our company’s “GMP-Plus” brand: We go above and beyond GMP in fulfilling individual customer wishes!

    What does GMP-Plus mean for our customers?

    On request, for example, we can provide guaranteed complete freedom from DNA residues or pyrogens, offer production under Class B Clean Room conditions if certain prerequisites are in place, or manufacture products 100% free of any human contact whatsoever.

    We can also carry out customer-specific tests, increase documentation levels or perform more in-depth validations.

    Protection against product piracy is becoming a subject of increasing focus within the pharmaceutical industry as well. European Parliament Directives 2001/83/EC and 2001/62/EU (to be implemented by 2017) and requirements of the FDA include measures to prevent counterfeit medications from infiltrating the legal supply chain. These guidelines were supplemented by Delegated Regulation (EU) 2016/161, passed by the Commission of October 2, 2015. We actively address the subject of counterfeit protection, and are the right contact partners for you in this regard.

    We will work with you to find the perfect solution, because your product is worth it!

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    Dominic Garrecht
    Head of Regulatory Affairs / Head of Quality Management