A
new chapter has been added to the
European Pharmacopeia
(5.1.2) on raw materials of biological origin for the production of cell-based
and gene therapy medicinal products. The chapter is for information only and
not legally binding.
The
chapter includes sections on the risk, origin, production of and quality requirements
for raw materials of biological origin used for the production of cell-based
and gene therapy medicinal products for human use.
The
chapter aims to assist stakeholders in ensuring raw materials are of suitable
quality and to foster harmonisation in the qualification practices and
standards to be applied.
This
chapter was published in the 9th Edition of the European Pharmacopoeia and became
effective on 1 January 2017.
Posted by Dr. Tim Sandle
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