Qualification/Validation

A risk-based approach that is clear and traceable. We have developed tools and methods to analyse your processes, systems, and equipment on a risk basis and document them in a GMP-compliant manner.

A clear guiding thread is crucial to the success of a qualification project. Together with you, we develop a holistic qualification approach in which all phases are structured and interlinked. The Validation Master Plan (VMP) defines strategy, scope, responsibilities, and interfaces and creates transparency regarding the approach, documentation, and milestones. This provides a robust, risk-based, and GMP-compliant foundation for the efficient implementation of your qualification and validation activities.

We take responsibility for the planning, execution, and documentation of all qualification phases—from Design Qualification (DQ) and Installation Qualification (IQ) through to Operational Qualification (OQ). Our services are tailored to your specific requirements and comply with current regulatory requirements as well as relevant standards and guidelines. With a structured, risk-based approach, we ensure that your equipment and systems are tested and documented in a traceable manner and commissioned in compliance with GMP.

We develop PQ concepts tailored to your processes and requirements. The focus is on a practical representation of your real manufacturing process. We capture relevant process parameters using measurement technology, evaluate them in a structured manner, and document all results in a GMP-compliant and traceable way. For this purpose, we use measurement procedures developed in-house as well as validated methods—for robust evidence of the performance of your equipment and processes under real operating conditions.

Whether integrity tests, temperature and humidity studies, or gas sampling—we perform all cleanroom measurements commonly used in the pharmaceutical industry using our own calibrated measuring instruments. Our qualified staff are specifically trained in the respective measurement methods and have extensive experience in the GMP-regulated cleanroom environment. This ensures precise, traceable, and standards-compliant measurement results—for measurable safety and stable processes.

In the pharmaceutical industry, there is no room for compromise: safety, quality, and compliance come first. To ensure your systems, equipment, and cleanrooms operate reliably over the long term, regular requalifications and calibrations are essential. We support you in meeting the stringent requirements of GMP guidelines:

Regulatory authority management in the GMP-regulated environment—confidence through clear communication
In the pharmaceutical industry, regulation and compliance are essential for the approval, manufacture, and distribution of your products. Effective regulatory authority management ensures that your processes always comply with current GMP requirements and that you can act confidently during audits, inspections, or queries from supervisory authorities. Structured regulatory authority management ensures that your processes always comply with current GMP requirements and that you can act confidently during audits, inspections, or regulatory queries. Our scope of services includes:

GMP consulting in the pharmaceutical regulated environment

We take a different approach to GMP consulting—practical, interdisciplinary, and with a deep understanding of the requirements of the pharmaceutical regulated environment. Our team brings together specialists from various disciplines under the leadership of a pharmacist with many years of hands-on experience.
This combination of scientific expertise, technical competence, and regulatory know-how enables tailored, efficient, and sustainable solutions—for lived compliance and safe processes.