Quality work has always been a core area of Life Science (pharmaceutical industry, biotech & medical devices) and the requirements have been constantly increasing over the years. Therefore, it is imperative for manufacturers that their quality departments function optimally in the balance between thoroughness and flexibility, and that the basis is always the applicable legislation and cGMP. QA employees are also in a context where there is constant change, as optimizations / LEAN are often part of the agenda. At the same time, the existing sets of rules are changed towards increased quality consciousness and risk evaluation - with optimized requirements for documentation as a consequence. The GMP rules are constantly under review, and one of the pervasive change measures is that there are increased requirements for risk assessments for new as well as existing products and processes. As a consequence, further systematic analyzes of the "root cause" are demanded / expected as well as a more risk-based approach on qualification and validation requirements. Similar changes are seen in conjunction with the analysis equipment being both more efficient and more sophisticated. This effect both the validation of the analysis method and of the equipment and the increased demands also requires further professional competences - including knowledge about IT / Automation and dataintegrity.
We work for many different customers in this exciting field and have in-depth knowledge of government requirements and other initiatives that the industry is undergoing. We are constantly working to improve our competences to stay ahead of the expectations for QA / QC set by both external stakeholders, such as authorities, and internal stakeholders.
AlfaNordic QA / QC delivers high-end services that are compliant with Eudralex Vol. 4, FDA 210 & 211, 21 CFR 820, 21 CFR part 11 and ISO 13485 including all guidelines. Our QPs can also act as QP delegates and quality auditors in all aspects of QA. In QC, we work with analysis methods, method development as well as equipment qualification and method validation. Finally, we handle ”Out-Of-Spec”/ “Out-Of-Trend” (OOS / OOT) and corresponding documentation.
In addition to this, we have strong consultancy expertise in food and comedy law.
The following are examples of our expertise within QA/QC:
We work based on Eudralex vol 4 and we can support with experienced quality consultants who can work both as Qualified Persons (QP), as QP delegates and as QP assistants. We have consultants with extensive experience within releases in all parts of the supply chain.
We offer comprehensive consultancy services in food and dietary supplements.
We offer comprehensive consultancy services in cosmetics
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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