ABSTRACT
Cleaning validation has come a longway since the days of
the Barr Laboratories Court Case and since the first FDA
guidelines referencing the subject of cleaning validation
were published in 1991. At that time, the requirements for
cleaning validation barely filled a single page of the Bulk
Pharmaceutical Chemical and Biopharmaceutical
guidance documents. Those documents were then
expanded to create the Guide to Inspection of Cleaning
Validations by FDA (first published in 1992 as a Mid-
Atlantic Inspection Guidance, then reissued as an FDA
guidance document in 1993). Today, despite nearly 15
years of exposure to the requirements for cleaning vali-
dation, this validation topic remains one of the areas of
validation that people frequently profess to know the
least about.
