Biomedical Engineering Reference
In-Depth Information
The logic of this investigative and remediation process
may be more or less explicit; it is quite explicit in the case of
GMPs. It is less explicit in other regulated areas. The
underlying logic remains.
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Even if an observation does, on occasion, lead to the
re-engineering of the GMP process, it does not necessarily
lead to the revision of a procedure. A CAPA can identify
several kinds of remediation for a given observation (e.g.,
business process redesign, risk mitigation, organizational
development programs, leadership development initiatives,
training intervention, etc.). Some intervention implicates
the revision of an operational SOP; other intervention
does not.
This section has discussed the function of SOPs and the
impact of change on life-cycle documents. It makes the point
that change opens the way for continuous improvement of
GMP processes in the life sciences industry. The next section
addresses the routine review of life-cycle documents.
1.3 Routine review of life-cycle
documents
The routine review of life-cycle documents takes place on a
regular schedule, typically every two years (biennial review)
or every three years (triennial review). Some controlled
documents, for example manufacturing orders, are
continuously reviewed. At the beginning of the life-cycle, the
specifi c version of the SOP is approved by management and
quality assurance (QA) and is then implemented or
“reissued.” Once implemented, like any controlled document,
the SOP remains subject to change control. Either it will be
unchanged during the life-cycle of that version, or it will be
changed according to the organization's change control
