Quality management based on GxP guidelines
Whether research or pharmaceutical production: we carry out qualifications and validations in accordance with the guidelines for Good Manufacturing Practice (GMP) - reliably, competently and traceably.
Everything under control right from the start
Are you planning a new system or want to optimize your processes? INNEXIS can support you. Our experienced GxP expert teams create risk analyses for your systems and develop individually tailored qualification concepts and strategies. If required, we can also take over project management, including planning, implementation, monitoring and coordination of all mappings, (re-)qualifications and validations.
Our teams are highly qualified. They not only have all the technical know-how, but also many years of experience in the pharmaceutical and life science sectors. In addition, our devices are DAkkS-traceable so that our measurements comply with all regulations. We provide you with all proof of tests and measurements as well as the documentation for the devices.
Your advantages at a glance
Our services are comprehensible, efficient, cost-transparent and, above all, secure. With INNEXIS, you benefit from
Always on the safe side - with qualification and validation
Qualification and validation are indispensable components of the manufacturing process in the pharmaceutical and life science industry. They ensure that every part of the production process runs according to specified quality standards. During qualification, we check whether your equipment and systems are functioning correctly and provide proof of their suitability for the intended purpose. With validation, we prove that all process-relevant steps lead to consistently high product quality.
Validation focuses on the processes and procedures within production and serves as proof of safe conformity. We check whether your processes and procedures consistently and reproducibly lead to the prescribed result and carry out a step-by-step
- process validation,
- transport validation,
- cleaning validation and
- computer system validation.
In this way, we prove that all processes meet the regulatory requirements and document this professionally and comprehensibly in accordance with ALCOA+ principles.
Only with a well-thought-out concept can the safety and quality objectives in laboratory and production areas be met in the long term. It is crucial that all systems and facilities function as planned. This is why the qualification of technical systems and rooms is a central component of Good Manufacturing Practice (GMP).
The legal basis for this can be found in the EU GMP guidelines (Annex 15) and in the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV), which prescribes the suitability testing of all quality-relevant facilities. In addition, Annex 1 and 11 as well as DIN EN ISO 14644 and VDI 2083 apply in order to systematically ensure the highest safety and quality standards.
The four phases of qualification
Whether it's a new or existing facility: we take care of the qualification of cleanrooms, technical systems and cold and deep-freeze rooms for you throughout Europe - regardless of manufacturer and in compliance with GMP. Qualification always comprises several phases:
Quality is our standard
We ensure that legal regulations and current standards are strictly adhered to, thus safeguarding your highly sensitive processes and products to protect patients.
Temperature mapping for quality assurance
We create detailed temperature profiles for systems, rooms and devices. We also record and document temperature distributions and fluctuations within a defined range. In this way, we ensure that the required quality standards are met and that your products are always produced, stored and transported under optimum conditions. This is an essential part of our services to ensure compliance and strengthen confidence in the effectiveness and safety of your products throughout their entire life cycle.
How temperature mapping works
Temperature sensors at various points in the system or room are used to measure the temperature over a certain period of time. The data collected makes it possible to identify critical areas and provides the basis for improving temperature control and monitoring.
Qualification of your systems
We offer special qualifications so that your systems can go into operation as quickly and safely as possible.
Modules and certain system components are often used in several places in systems and companies. We simplify the necessary qualification processes by pre-qualifying individual standardized system modules. The more modules are individually qualified in advance, the faster a new system can go into operation.
If a specified system is manufactured in large quantities with the same technical design and functionality, it is considered a type. This includes pharmaceutical transport boxes, refrigerators, transport refrigerated vehicles and incubators. We qualify such types. The initial basic qualification serves as proof for all identical devices.
Looking for an individual solution in the area of qualification and validation?
Our experienced GxP expert teams will be happy to provide you with an offer that is tailored precisely to your requirements.