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 5: 'Production' -
improved guidance on prevention of cross-contamination (cross referencing with
Chapter 3). Changes also introduced a new section on the qualification of
suppliers in order to reflect the legal obligation of manufacturing
authorisation holders to ensure that active substances are produced in
accordance with GMP and supply chain traceability. Sections were inserted to
clarify and harmonise expectations of manufacturers regarding the testing of
starting materials.
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.
Posted by Tim Sandle
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