Sunday, 14 April 2013

PDA CLEANING VALIDATION–CLEANING CONTINUUM

Slide1Pda

2.1 Use of the Cleaning Continuum
The intent of this section is to describe the limits of the cleaning continuum (see Table 1).

These limits represent the extremes in the range of operating differences found within the industry which
preclude a uniform approach.

At each end of the continuum, the cleaning validation requisites are
either simple or complex.

Recognition that there are many of these coupled limits, and that each
cleaning process has a unique place within each level of the continuum, explains why specific
industry-wide approaches have been so difficult to develop.

 

………..continues

New Tab

No comments: