Commissioning and Qualification
Progress has completed an extensive portfolio of Commission and Qualification projects for clients producing small molecules, biologicals (proteins, MAbs, blood products) or ATMP (cell and gene therapy products).
We take the production process as the starting point for our qualification strategy for qualifying process and QC equipment and the GMP cleanrooms and associated utilities.
Our qualification expertise includes process equipment (upstream, downstream, filling and finishing, freeze drying, capsulation and visual inspection systems), QC lab equipment, HVAC systems, gases, clean steam, water, cleaning validation, computer system validation, etc. We take a risk-based approach as per ICH Q8 and Q9.
We possess in-depth knowledge of (bio-)pharmaceutical processes, GMP and technical requirements for equipment, utilities and cleanrooms. We use this knowledge to clearly define the required qualification and validation strategy and generate your Validation Master Plan (VMP) and/or Validation Project Plan (VPP) and qualification documentation for each critical system. This includes the process validation and analytical methods validation strategy, as well as the equipment, utilities and cleanroom qualification strategy.
Whether it concerns your newly built cleanrooms in an already existing GMP facility or a brand new GMP facility, we will define the most appropriate strategy using a risk-based approach. With our solid expertise in performing risk analyses in accordance with ICH Q8 and Q9, we determine the critical processes, installations and/or functionality in your organization. We then use the results to further assess these critical processes, installations or functions. The final results of the risk analysis reflect the right development, implementation and qualification strategy. Among other things, the strategy will indicate for which systems commissioning is sufficient, which systems require qualification and which criteria should be applied to commission plans and results with relation to qualification protocols.
Planning and Implementation
We can assist you with an experienced team of qualification engineers and a project manager. The qualification manager is responsible for the planning and execution of the qualification activities. All possibilities, impossibilities, risks and time-critical action points are identified in advance, resulting in accurate planning and budgeting. All business and GMP risks will be closely monitored and timely action will be taken to prevent delays or mitigate business and/or GMP risks. If required, the project manager escalates to the steering committee and proposes mitigating measures.
From the outset of the project, the team can help you define URS requirements and draft the URS-es of your new cleanroom, utilities and equipment, and advise you on the selection and procurement process. Then we can carry out the Design Qualification and review the suppliers’ commissioning plans and witness the commissioning execution to ensure that the commissioning results can be used in the qualification. Subsequently, the team will prepare and implement qualification protocols and write the reports, including general qualification summary reports.
Our consultants are experts in this way of working and can guide your projects through the various phases as per planning and budget. They can perform following roles:
- Project Manager
- Process Engineer
- Construction Manager
- Qualification Engineer
- Computerized System Validation (CSV) Engineer
- Cleaning Validation (CV) Engineer
Throughout the project, Progress consultants follow the applicable guidelines and advisory documents, including ISPE, GMP, FDA and GAMP.