The approach of this guideline represents a complete paradigm shift. The responsibility for ensuring the pharmaceutical’s perfect quality in terms of “elemental impurities” is now entirely borne by the authorization holder. Moreover, it is a comprehensive approach that comprises all aspects of production (excipients, API, container closure systems, drug product) under GMP requirements. Then, if necessary, suitable corrective measures should then be derived from the risk assessments in order to elevate and ensure the quality of the pharmaceutical product. Particularly for smaller and medium-sized companies, that potentially could entail tremendous efforts for their staff, financial expenses, and logistical issues, since they may lack the required expertise in these fields or the appropriate concepts for solving these issues.
The GBA Laboratory Group’s pharmaceutical site in Neu-Ulm – Phytos Labor für Analytik von Arz-neimitteln GmbH & Co. KG – has developed a simple and practical concept based on an approach that mixes the options mentioned in the guideline for creating the risk assessment. It mainly focuses on Option 3 stated in the guideline: “Test Final Drug Product.” At the outset, matrices are generated for the customer, e.g. shared excipients, suppliers, subcontractors, production processes, etc. in order to identify overlaps in the customer’s individual product range and avoid excess efforts and costs. Furthermore, product groups are also identified that can be evaluated in combination.
As one-stop shopping for all your analytical services, our Pharmaceutical Division’s locations in Neu-Ulm (Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG), Gräfelfing, and Martinsried (LPU Labor für Pharma- und Umweltanalytik GmbH) offer comprehensive consulting, analytical and microbiological testing, complete registration services, and QP services for market authorization.
In the analytical field, the GBA Laboratory Group also provides all of the required services (ICP-MS screening processes, verification of methods, validation of methods, batch testing) under cGMP conditions.
With competent project managers, long-term experience in the analytical field and with authoriza-tion procedures, as well as a wide-ranging analytical portfolio, the GBA Laboratory Group is the competent partner that can reliably accompany you throughout the entire process of monitoring elemental impurities.
Meet us in person at the CPhI 2016 in Barcelona: Wednesday, October 5th, 2016 (4:30 – 5:15 p.m.), Theater Two