By Anonymous on Friday, January 4, 2002 - 01:51 pm:
Where and how do you get the specifications for the maximum amount of the contaminate?
By B.Buglio on Monday, January 7, 2002 - 06:32 am:
The following articles should be useful. All are
in Pharmaceutical Technology: two by Destin
LeBlanc Oct 2000 and Oct 1998 addressing API’s and
finished drug products rsp. The third is by
Fourman and Mullen, April 1993. The latter
describes the criteria established by E.Lily. All
three criteria must be met: no more than 0.001
dose of any product will appear in the max daily
dose of another product, no more than 10ppm of any
product will appear in another product and no
quantity of residue will be visible on equipment
after cleaning.
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