Friday, December 18, 2009

Got Animal-Derived Materials? Part 3

By Dr. Ray Nims

The assessment of viral and transmissible spongiform encephalopathy (TSE) risk for animal-derived materials (ADM) used in the manufacture of biologics, which we have described in previous blogs, is just one component of an overall ADM program that should be in place at each organization producing biologics.

A formal ADM program at a biologics manufacturer ideally should be driven by an overriding SOP or policy document. This should address the procedures in place for minimizing the use of ADM, for procuring ADM with a view to minimizing viral and TSE risk, and for assessing the viral and TSE risk associated with the ADM that are used. There are specific sourcing requirements for ADM that are intended to minimize TSE risk (EMEA/410/01 Rev. 2 October 2003), and these must be followed or justification provided if deviated from. The evaluation of ADM for the presence of viruses of concern is addressed in the Code of Federal Regulations, Title 9 Part 113.53. ADM viral and TSE risk assessments should be conducted according to a formalized procedure by teams of individuals with education, training, and/or experience appropriate for these tasks. The composition of the risk assessment teams and the qualifications of their members should be described in revisable controlled documents. The risk assessments themselves should be recorded in controlled documents which may revised as new information becomes available from the ADM suppliers. The ADM information that is used as part of the risk assessment process should be archived in a manner tying it to the risk assessment itself.

The existence of a formalized ADM program, qualified risk assessment teams, as well as reports documenting the individual ADM risk assessments may be the subject of regulatory scrutiny during periodic inspections or inspections tied to a new product application. This is especially likely if the product is intended for global distribution, as these ADM issues are specifically mentioned in EP (Chapter 5.1.7) and EMEA (EMEA/410/01 Rev. 2 October 2003) guidance.

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