Change Control goes to the core of pharmaceutical operations.  Most FDA 483 observations are written to cite a lack of control of the plant.  If change control is weak, the plant is out of control.  What changes are worth spending a lot of time effecting and what changes can be made effective by an individual acting in accordance with their assigned duties?  This is the question that compliance and regulatory people have pondered for a long time.  The cost implications can not be underestimated by simply stating that all changes are critical and therefore need to have a lot of paper work to effect and ever increasing costs to maintain the status of the change control.

Our Approach

Determination of Criticality and Complexity

Determination of criticality and complexity is essential to assessing the appropriate level of change control.  A matrix system for determination of the appropriate change control level is a useful tool for making this assessment.  The first matrix is the criticality determination.  If the assessment of the effort results in any one the four major categories on the left placing the effort into the high or very high columns then the entire effort is placed in this level of criticality or complexity.

The following is a schematic representation of the change control scope.  The results of the criticality and complexity matrices leads to the appropriate change control or validation effort described in the previous table.  The results are determined as follows:

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