[RegAffairs]Re: QC reporting to production

[bruce berger <bergerb2@yahoo.com>]

the proposed cgmp rev - circa 1969 had this as a
requirement - if one reads the preamble to the final
rule is was taken out - primarily because it was felt
that it went to far in defining "how' the qcu's
independence should be accomplished.

hence it was taken out of the final rule

bruce berger
cmc applications