Changes
to EU GMP this year include:
Chapter 3: 'Equipment and
Facilities' - updated guidance on preventing contamination including using
Quality Risk Management principles to assess and control the risks. Depending
of the level of risk, it may be necessary to dedicate premises and equipment
for manufacturing and/or packaging operations to control the risk presented by
some medicinal products.
Chapter 7: 'Complaints,
Quality Defects and Product Recalls' - extensive changes have been made to this
Chapter which now reflect that Quality Risk Management principles should be
applied when investigating quality defects or complaints and when making
decisions in relation to product recalls or other risk-mitigating actions. It
emphasises the need for the cause(s) of quality defects or complaints to be
investigated and determined, and that appropriate preventative actions are put
in place to guard against a recurrence of the issue and clarifies expectations
and responsibilities in relation to the reporting of quality defects to the
authorities.
In
addition to the main chapters:
Annexe
15: Qualification and Validation' - new version to be implemented in October
2015.
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