The proper qualification and validation of pharmaceutical manufacturing pieces of equipment and the associated manufacturing processes are critical requirements for ensuring the guaranteed quality and safety of pharmaceutical manufacturing processes and the resulting products.
The Quality Assurance experts of our company join the projects already from the start of the design phase on, in order to ensure the right quality of our machines and installations according to the expectations of our customers. This approach enables the company to build manufacturing pieces of equipment that is capable of reliable producing of quality products.
In order to ensure the right design, installation and functions of the products in scope in compliance with the strict c-GMP guidelines as well as that of the URS and the PO, we provide our customers with all the necessary DQ, FAT and SAT (IQ, OQ) documentations, both in English and German languages. For documentations in other languages please ask our sales colleagues.
The required CE certifications and the manuals of the equipment are typically provided in the official language of the country in which the machine is installed.
Based on special customer needs, we are also capable of preparing state-of-the-art Traceability Matrix, GMP Risk Assessment, DoE based extended OQ and PQ plans according to the QbD approach and any other documentations.
Our independent consultants can also take over the full preparation and execution of the qualification package, from identifying your needs all the way to hand over of the installations to start GMP production.
In case of customer interests, we can also provide our customers with suitable SOP blocks regarding operation, maintenance, cleaning and calibration of the products that you can easily implement into your SOP system helping our customers to keep the target delivery dates and realize the project on time.
In order to define the scope of regular preventive maintenance and calibration services as well as the contractual conditions of any unplanned repairs and trouble-shooting activities, we can provide you with suitable Service Level Agreements, Maintenance Plans and Calibration Protocols.