Qualification and validation are critical requirements for certified stable manufacturing processes and product safety. The validation services specialists at Harro Höfliger are involved as early as during the development phase of your equipment, allowing them to identify the critical areas in the production process and to account for them in the design of the system. This guarantees a focus on the operator plus efficient and economic validation processes, which account for the strict GMP guidelines. Our service support includes complete pre-qualification at our facilities, which can be carried out after machine acceptance (FAT) in our testing rooms even with the original product.
Our validation and qualifications include the exact requirements that you need: Based on a risk evaluation, the scope of testing focuses on the critical production steps especially. In addition to standard EU and US GMP-compliant processes, we also offer tailor-made validation packages.
A successful project requires that we clearly understand the validation and documentation needs of our customers. We hold a kick-off meeting, in which our validation managers clarify all requirements together with the customer and then define the scope of a binding strategy.
The pre-qualification at our facility can also be done using the original active ingredient product. This guarantees certainty that all production processes run smoothly. Moreover, this also significantly reduces the time needed for initial setup and qualification after equipment has been installed at the customer’s location.
How do you integrate validation services into a project?
In the early project phase, our validation managers review customer requirements (URS, user requirement specifications) of the machine and documentation and input their comments on the requirements into the supplier response matrix (SRM). This is followed by the initial validation meeting with the customer in which the project-specific qualification method is discussed and agreed upon. We prepare a qualification master plan for proceeding.
What are your next steps?
Critical processes that may have an impact on the quality of the product are identified in the risk analysis (FMEA). The scope of testing for the installation, functional and performance qualification of the equipment and the validation of the computer-aided systems (CSV) are defined by the FMEA.
What role does documentation play?
Detailed reports and a seamless documentation are mandatory in the GMP environment. The transparency of this information must be guaranteed at all times. For this reason, we prepare structured documents for clean verification that product safety and consistently high quality are guaranteed.
Does the validation project end after commissioning?
We ensure that our systems meet all legally defined requirements throughout their entire life cycle. Our experienced experts are very familiar with each specific machine and ensure, for example, that after retrofitting or upgrades, they are efficiently re-qualified and re-validated.
Do you have questions for us? Get in touch!