The
European Medicines Agency has published the following concept paper ‘Guideline
on process validation for finished products -information and data to be
provided in regulatory submissions’.
Process
validation can be defined as documented evidence that the process, operated
within established parameters, can perform effectively and reproducibly to
produce a medicinal product meeting its predetermined specifications and
quality attributes. Continuous process verification has been introduced to
cover an alternative approach to process validation based on a continuous
monitoring of manufacturing performance. These concepts form the basis of the
new guideline.
The
guideline is brought into line with ICH Q8, Q9 and Q10 documents and the
possibility to use continuous process verification in addition to, or instead
of, traditional process validation described in the previous guideline has been
added and is encouraged. This guideline does not introduce new requirements on
medicinal products already authorised and on the market, but clarifies how
companies can take advantage of the new possibilities given when applying
enhanced process understanding coupled with risk management tools under an
efficient quality system as described by ICH Q8, Q9 and Q10.
Posted by Tim Sandle
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