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Re: qualification of working reference standards
The questions are really "what did you use as the primary standard?" and "how well validated are your methods?" Although NMR and LC-MS may be and probably is, overkill, I can envisage situations where the customer feels that it is necessary. A well made and well written case should help resolve this. Malcolm Ross Generapharm-Training and Consultancy Basel-CH The GMP Discussion Group is sponsored by gmp review - see http://www.pharmweb.net/gmp.html |
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