Project management and support

Working with QbD means working with strong project managers, experienced in various types of projects. We are happy to offer optimal project management and support for your company. What can you expect?

Besides our main fields of action – validationregulatory affairs and quality assurance – QbD is the full-service partner in project management and support for various topics and projects in the field of quality management. Often, these projects require very specific knowledge and a combination of different skills. Thanks to our broad expertise, we are also able to take care of your projects in the fields of technology transfers, new product introductions, process development and support, packaging and serialization and master batch records.

Technology transfers and new product introductions

The introduction of a new product on the market or the outsourcing or relocation of a product location: it all asks for an efficient transfer of technologies between all parties involved. To optimally design this technology transfer process, project management, qualification, validation and regulatory skills are required. Our QbD Lean Technology Transfer Framework offers a risk-based approach combined with templates to ensure an efficient technology transfer between sending and receiving units at all times.

Process development and support

QBD has over 8 years of experience in Computer Systems Validation. Our competences include training in Project Management, Qualification and Validation of Computerized Systems based on Risk Management (according to the GAMP 5®), Good Manufacturing Practices (GMP), Process validation and quality management systems. This ensures the correct planning and execution of your validation project.

QbD’s CSV experts are experienced in validating pharmaceutical computer systems and pharmaceutical software, including:

  • Manufacturing Execution Systems (MES)
  • ERP Systems (SAP, JD Edwards …)
  • Laboratory Information Management Systems (LIMS)
  • Electronic Batch Record (EBR)
  • Manufacturing Resource Planning Systems (MRP)
  • Lab system software (HPLC, FTIR, GC, etc.)
  • Document Management systems
  • SCADA systems

Packaging and serialisation

Every pharmaceutical process is different. If you want to scale up your processes, for example in case of a technology transfer, you need to adjust them. Our more than 300 experts with academic backgrounds are happy to support you in adjusting and optimizing your processes, for example by making them more consistent and robust or improving their yield. We even developed our own software tool that enables us to analyze which steps influence the end result the most, how we should set up our design of the experiment, and more. Everything to guarantee optimal processes.

To prevent the spread of falsified medicines, more and more governments are enacting new legal requirements to enforce anti-counterfeiting measures in the supply chain. For example serialization technology to be able to distinguish genuine medicines from counterfeited ones, by providing unique serial numbers for each packaging. In many countries, serialization is statutory and that’s why companies need to convert their production lines to enable serialization.

Master batch records

Whether you want to migrate from an existing to a new eBR system or you just started using an eBR system for the first time, batch records need to be built into the system before bringing it into use. This requires insight in how the system works, what the production process looks like and what the critical parameters are. After all, it’s important to not only translate one system to another, but also to improve the new system in line with its technical possibilities. Our experts help you to arrange your system and set up your master batch records.

More information about what our project engineers can do for your company and how we handle different projects?