Biomedical Engineering Reference
In-Depth Information
The CCP decision tree analysis process is described as follows:
1. Is there a microbial hazard at this step? If the answer is “No,” then the
process step is not a CCP. If the answer is “Yes,” then proceed to ques-
tion #2.
2. Do preventive measures exist for the microbial hazard? Consider the mea-
sures in place in your hazard analysis chart. If the answer to this question
is “Yes,” then move to question #3. If the answer is “No” and control
measures are not in place, then consider whether control is necessary for
product safety. If control is not necessary, then the process step is not a
CCP. If control is necessary and no process control measures exist, then the
product or process should be modified at this step or some earlier or later
stage to include a control measure. If a control measure is not possible,
then consider the introduction of a new procedure to build in control.
3. Is the step specifically designed to eliminate or reduce the likely occurrence
of the hazard to an acceptable level? The question refers to the process step
and is really asking whether the step itself controls the microbial hazard.
If the answer is “Yes,” the process step is a CCP. If the answer is “No,”
then proceed to question #4.
4. Could contamination occur or increase to unacceptable levels? The answer
would be based on the hazard analysis information, the team's expertise,
and literature references. It would be important to consider such factors as
the effect of immediate environmental or facility design; possible cross-
contamination from personnel, other products, or raw materials; possible
contamination from equipment or utilities; physical conditions, e.g., hold
times, temperature; product or raw material buildup in dead leg spaces; or
any other factors or conditions that could cause bioburden to increase in
the decision. In addition, any additive effects during the process that may
increase bioburden should be considered. If the answer is “No,” then the
step is not a CCP. If the answer is “Yes,” move to question #5.
5. Will a subsequent step or action eliminate or reduce the hazard to an accept-
able level? This question is designed to allow the presence of a microbial
hazard at a particular step if it will be controlled later in the process. If the
answer is “Yes,” then the step is not a CCP. If the answer is “No,” then
the process step is a CPP.
Each question in the decision tree is addressed for each process step until the
determination is made that the step is a CCP or not a CCP. Figure 11.5 illustrates
the decision tree analysis for process step 4.0, “Open container and use drum
inverter to charge mill.” The results of the decision tree analysis concluded that
the process step was not a CCP.
Figure 11.6 illustrates the decision tree analysis for process step 4.1, “Turn
on equipment with heated air for 30 min and visually check for dryness.” The
decision tree analysis concluded that this process step is a CCP.
Search WWH ::
Custom Search