In July the Food & Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) published a list of approved exceptions or alternative procedures regarding blood products. If specific circumstances require exceptions or alternative procedures to any requirement in sub chapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products, they can be approved by the CBER. Every request requires submission of supporting data unique to the circumstance. Publication of these approvals for a specific exception or alternative procedure does not necessarily mean that they can be generally applied to other manufacturers.
In general, requests should be submitted in written form. In special cases, though, an oral request is possible. However, the necessary written documentation has to follow as quickly as possible. The request for exception or alternative procedure should be submitted in accordance with 21 CFR 601.12 and may reference the "Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001)".
More information about approved exceptions you will find here.
Please note ECAs Education Course cGMP Compliance for Biopharmaceuticals in Neu-Ulm, Germany on 4/5 November 2009. This course will provide you with the theoretical background about the regulatory requirements and practical experiences of implementation as well as with the practical side through a site visit at Rentschler Biotechnology.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)
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