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As reported in our
GMP
Newsletter from 31 May 2007 the new guideline concentrates on a continuous
improvement process and also emphasises further elements supporting the life
cycle approach:
- CAPA
- Change Management
- Technology Transfer (seen as basis for
process control, process validation and a continuous improvement process)
For instance, the document indicates that a pharmaceutical
company should have established a system to take corrective and preventive
measures (CAPA). These can possibly follow from complaints,
deviations, recalls or observations at audits, inspections or from
monitoring results. The analyses within the system should aim at identifying
the real cause. The result should be a better process and product
understanding, from which improvements are derived.
A continuous improvement can, of course, lead to changes. For
that reason an efficient Change Control/Change Management System is
required. It is important to differentiate between changes before and after
authorisation though, when regulatory requirements determine the procedure.
Proposed and possibly necessary changes should be evaluated in a risk
analysis to estimate potential regulatory consequences. Ultimately all
changes have to be recorded and evaluated – before as well as after the
change.
The changes that were part of the process development,
deliver documented information and the necessary process understanding to
partly transfer complex process successfully; irrespective if it is a
transfer from the galenics development to production or a transfer of an
already validated product to another site.
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