End-to-end GMP services: Consulting, Planning, Qualification
QP-Engineering: Your GMP Specialist for Pharma and Life Sciences
What is GMP?
GMP, short for Good Manufacturing Practice, is the binding quality framework for pharmaceutical and Life Sciences manufacturing in the EU. Compliance is enforced through routine inspections by national authorities and the EMA. QP-Engineering helps you reach and maintain GMP compliance, and prepares you for inspection.
QP-Engineering: Your Partner for GMP
End-to-end GMP delivery from a single partner.
What you gain with QP-Engineering as a GMP partner:
GMP services for pharmaceutical manufacturing
QP-Engineering knows what EMA, FDA, and national inspectors look for in pharmaceutical operations. Our team has years of practical experience across the pharma value chain, including facility design and qualification, validation, contamination control, team training, and inspection readiness. We support solid dosage and sterile sites, contract manufacturers, and in-house manufacturing operations of biotech and Life Sciences companies.
Pharmaceutical water systems: PW, WFI, and pure steam
Water plays a central role in pharmaceutical manufacturing, and pharmacopoeial compliance is required at every step. We design, qualify, and commission pharmaceutical water systems for Purified Water (PW), Water for Injection (WFI), and pure steam, all meeting Ph. Eur. and USP requirements.
We support you from initial concept and URS through generation and distribution design, installation, IQ/OQ/PQ, and release for production use. If you already have an installed system that needs requalification or troubleshooting, we step in there too.
Pharmaceutical water systems: PW, WFI, and pure steam
Water plays a central role in pharmaceutical manufacturing, and pharmacopoeial compliance is required at every step. We design, qualify, and commission pharmaceutical water systems for Purified Water (PW), Water for Injection (WFI), and pure steam, all meeting Ph. Eur. and USP requirements.
We support you from initial concept and URS through generation and distribution design, installation, IQ/OQ/PQ, and release for production use. If you already have an installed system that needs requalification or troubleshooting, we step in there too.
YEARS AT THE LEADING EDGE OF GMP
The QP-Engineering team
Our consultants combine specialist GMP expertise with hands-on plant experience. We work alongside production, QA, and engineering teams to make GMP compliance practical and workable, rather than treating it as a documentation exercise.
Simon Menges
Owner, M. Eng. Mechatronics
The most rewarding part of my work is sitting down with a customer, mapping out the project, building a roadmap, and getting it done.
The QP-Engineering team
Our consultants combine specialist GMP expertise with hands-on plant experience. We work alongside production, QA, and engineering teams to make GMP compliance practical and workable, rather than treating it as a documentation exercise.
Melissa Rensland
Managing Director and Sales Manager
I value open communication and a real connection with customers. At QP-Engineering, every project becomes a genuine partnership.
Simon Menges
Geschäftsführung, M. Eng. Mechatronik
The most rewarding part of my work is sitting down with a customer, mapping out the project, building a roadmap, and getting it done.
Melissa Rensland
Managing Director and Sales Manager
I value open communication and a real connection with customers. At QP-Engineering, every project becomes a genuine partnership.
Simon Breitenbach
Dr. biol. hum., GMP Consultant
I enjoy taking a tangled set of GMP problems, breaking them into manageable pieces, and working through each one with the customer.
Simon Breitenbach
Dr. biol. hum., GMP Consultant
I enjoy taking a tangled set of GMP problems, breaking them into manageable pieces, and working through each one with the customer.
Elena Haugg
Dr. rer. nat., GMP Consultant
Success lives in the details. I am motivated by understanding and refining those details so our customers stay ahead.
Elena Haugg
Dr. rer. nat., GMP Consultant
Success lives in the details. I am motivated by understanding and refining those details so our customers stay ahead.
Petra Sebestyen
Dr. rer. nat., GMP Consultant
Theresa Friebis
Biologist, GMP Cleanroom Specialist
Elfi Thudt
Sales Manager
Michaela Weichselbaumer
Office and Process Manager
What our partners say
Thanks to QP-Engineering, we passed our inspection cleanly and feel ready for the next one.
Frequently asked questions about GMP
GMP makes sure pharmaceutical products are safe, effective, and of consistent quality. The framework covers the entire manufacturing chain, including raw materials, equipment, environment, personnel, processes, packaging, and labelling. The goal is to minimise risk to patients.
GMP compliance is legally required for companies manufacturing pharmaceuticals, biologics, and certain cosmetics and food products. The framework is set by regulators such as the EMA, FDA, and national authorities, and it underpins patient safety and product release.
Most quality standards focus on the end product. GMP covers the entire manufacturing process, from raw materials and the production environment through to equipment, personnel actions, processes, and packaging, all the way to the finished product released for shipment. Every link in the chain has to be qualified, controlled, and documented.
GMP compliance is verified by national and international health authorities. These include the EMA, FDA, and national regulators such as BfArM (Germany), MEB (Netherlands), DKMA (Denmark), and HPRA (Ireland). They carry out both routine and for-cause inspections.
Regulators respond to GMP findings in proportion to their severity. Outcomes range from observations and warning letters to consent decrees, batch holds, recalls, and withdrawal of the manufacturing authorisation. Recalled product means significant cost and reputational damage for the manufacturer. Consistent compliance and regular internal self-inspection are the most reliable way to avoid these outcomes.
