Freya Wolles Business Development Manager Q +32 496 77 45 14

Facility and Process Support

QUALITY ORIENTED PRODUCTION PROCESS

The quality of medicines can only be guaranteed if the whole production process is closely monitored and complies with the legal regulations. For this reason, all the processes, procedures and machines in a controlled production environment are subject to strict requirements.

Ordina developed for you a unique science & risk based solution and ensures that all rules and legally necessary checks (including PAT, ICH Q8, Q9 and Q10) are applied. This allows you to reach the desired quality level quickly and efficiently.

Concept

Ordina’s own Quality & Compliance experts support you during the GMP compliance process. We do this in the different stages of the process: FAT/SAT, FMEA, Process & Cleaning Validation, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Approach

Ordina can boast an in-depth knowledge of relevant rules and legislation applicable during process design, qualification and verification. Quality by Design (QbD) and the associated “Design Space” and “Critical Quality Attributes” occupy centre stage. Quality is built in at the design phase. We guide you smoothly through the qualification and validation of your processes.  

Result

Thanks to the validated manufacturing process, you produce consistently high-quality products and comply with the applicable legislation. Furthermore, at the end of the process you have the necessary data and tools to continue to monitor your process and further optimise performance.

Facility and Process Support Contact Contact Freya Wolles