Pharma & Compliance
The manufacture of pharmaceutical products is subject to strict national requirements such as the Therapeutic Products Act (HMG) in Switzerland or the Medicinal Products Act (AMG) in Germany. The internationally recognized regulations of the US Food and Drug Administration (FDA) must be observed as well. These requirements apply not only to the manufacturing process itself but include the entire project planning of a pharmaceutical plant. The guidelines of good manufacturing practices (GMP) must also be taken into account when formulating the project and must be observed in all its phases.
These regulatory requirements apply regardless of the form of administration and the type of process used, although there may also be country-specific requirements and specific, process-related requirements for the respective processes. Therefore, the combination of our in-depth GMP knowledge, our project experience in the pharmaceutical industry and our customer-oriented way of working are the best prerequisites for guaranteeing a successful and solution-oriented implementation of your pharmaceutical project.
Regardless of whether it is a matter of setting up a new system or converting an existing system, we can offer you our support in the entire project chain, from the initial idea to the product launch. HINE has extensive specialist knowledge and experience in the areas of:
- Active ingredient manufacturing (API)
- Manufacturing solid, semi-solid and liquid dosage forms
- Sterile filling (ampoules, vials, and tubes)
- Packaging systems
- Product transfer
- Clean room planning and commissioning
We have a corporate structure that ensures that our employees can complete tasks quickly and efficiently. We pay attention to providing the highest quality services possible to fully meet any GMP requirements.
Qualification & Validation
In addition to technical expertise, our engineers are also trained in project management taking into account official requirements. That is why we can offer you support throughout the whole project process. This includes the implementation of feasibility studies, project planning and budgeting, the processing of the various design phases (concept, basic, detail) as well as project management and commissioning on site. We can support you in all the phases of your project when carrying out the work involved and preparing the necessary documents.
We can support you in all the phases of your project when carrying out the work involved and preparing the necessary documents. This includes, among other things:
- preparing the user requirement specifications (URS)
- implementing risk analyzes (RA)
- creating and implementing a qualification concept from design qualification (DQ) through installation qualification (IQ) to operational qualification (OQ)
- supporting process validation/performance qualification (PQ)
- preparing the necessary standard operation procedures (SOP) and
- participating and managing factory acceptance tests at the supplier (FAT) as well as at your site (SAT).
We are also happy to help you with any process-related discrepancies and to work out strategies to sustainably optimize your processes. Taking this opportunity to increase your production quality and efficiency will save time and money and lead to an advantage over your competitors.