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.
- Developing an understanding of the processes of early accounting for GMP aspects
- Preparing quality schedules and seamless documentation
- Preparing a qualification master plan (QMP) and test documentation
- Performing risk analyses (FMEA)
- Qualification according to EU and US GMP standards or completely tailored to customer specifications
- The option to completely pre-qualify in our own internal testing rooms
- Conducting qualification tests at the customer’s location
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.
Pre-qualification with Verum
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?
At an early stage of the machine project, our validation managers review customer requirements (specifications) in all areas of qualification and input their comments on the requirements into the supplier response matrix (SRM). This is followed by the qualification kick-off, during which the project-specific qualification procedure is discussed and agreed with the customer. The results are finally documented in the qualification master plan (QMP).
What are your next steps?
The risk analysis (FMEA) identifies and evaluates critical processes that have an influence on product quality. The FMEA then determines the scope of test activities (installation and functional qualification) and the validation of computer-aided systems.
What role does documentation play?
Comprehensive protocols and complete documentation are essential in a GMP-regulated environment. Transparency and consistency of information must be guaranteed at all times. The Validation Services team therefore prepares structured documents for GMP-compliant proof that our machines constantly manufacture a product that conforms to specifications.
Does a qualification project end after the Site Acceptance Test (SAT) has been carried out?
No, we ensure that our machines meet all statutory requirements throughout their entire life cycle. Our experienced experts also provide support in carrying out the necessary change control after conversions at the customer's request, thus ensuring efficient re-qualification.