Qualification and validation take up a lot of space and require extended efforts in the pharmaceutical production, it is therefore natural that this discipline constitutes a larger part of AlfaNordic’s many competencies. We offer our customers support within qualification and validation of facilities, equipment, processes (API, Aseptic, Packing), cleaning validation and IT/automation. We perform tasks for our customers with short notice within projects of a shorter or longer duration. Our skilled employees offer assistance with or performs validation management (Project Management), planning, design, practical execution of validations and assessment of existing validations. We can lead, perform reviews and perform Quality Assurance (also in the role of QA) or we ourselves can prepare the necessary documentation during the product’s entire lifecycle, or during part of it.
Validation and qualification are performed on facilities, equipment, processes (API, aseptic, packing, cleaning validation and IT / Automation. We assist with PQ and PV as well as Cleaning Validation. We can lead, perform reviews and perform Quality Assurance or we ourselves can prepare the necessary documentation.
The following are examples of our expertise within validation:
We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:
AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.
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