GMP for excipients: new EU rules on raw materials, packaging, tracking
The final risk assessment guide is stricter and more detailed than the draft form published in February 2013. It requires excipient makers to risk assess their entire supply chain, from raw material sources, to stability, cold chain management, and suitability of packaging. They also need to put in place “systems for coding and identifying starting materials, intermediates and excipients to allow full traceability.”
Under the new rules, manufacturers should identify risks to the safety and stability of excipients, from their source (animal, mineral, vegetable, or synthetic) all the way through to their incorporation in the finished dose form.