Written Operating Procedures

The various activities and responsibilities associated with retrospectively validating
a product must be put in writing. All too often this simple but crucial
step is omitted for the sake of expediency only to find at a later date that the
Copyright © 2003 Marcel Dekker, Inc.
initial assumptions cannot be recalled. Aside from maintaining consistency, a
written procedure to describe the work being performed satisfies the intent of
the current good manufacturing practice (CGMP) regulations.
In general, the written operating procedure should delineate in reasonable
detail how the validation organization will function. Not every situation can be
anticipated, and this should not be the goal. There should be sufficient detail,
however, to ensure consistency of performance in an undertaking that may continue
for several months. In the preparation of such a document, the following
questions should be answered:
1. Which organizational functions will be represented on the validation
committee?
2. What mechanism exists for validation protocol preparation and approval?
3. What criteria are used to select critical process steps and quality control
tests for which data will be collected?
4. How often will the committee meet to ensure prompt evaluation of
study data?
5. Who has responsibility for documenting committee decisions? For
report preparation?
6. Is there a provision for follow-up in the event of unexpected findings?
7. Where will the original study data and reports be archived?
In the preceding discussion of areas of interest to the validation organization,
two concepts were introduced that deserve further clarification: (1) critical
process steps and quality control tests that characterize the operation, and (2)
validation protocol.