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BIOTECHNOLOGY - GUIDANCE ON THE ASSESSMENT OF THE PURITY, BIOLOGICAL ACTIVITY AND STABILITY OF MICROORGANISM BASED PRODUCTS
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-1999
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
ForewordIntroduction1 Scope2 Definitions3 General considerations4 Validity of purity assessment5 Validity of biological activity assessment of product6 Validity of stability assessmentAnnex A (informative) Bibliography
Provides guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. Also applies for purposes of product registration.
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