The EMA
has published industry comments gathered during its public consultation for the
ICH draft guideline on pharmaceutical product lifecycle management (ICH Q12).
This
new guideline is proposed to provide guidance on a framework to facilitate the management
of post-approval chemistry, manufacturing and controls (CMC) changes in a more
predictable and efficient manner across the product lifecycle. This guideline
aims to promote innovation and continual improvement, and strengthen quality
assurance and reliable supply of product, including proactive planning of
supply chain adjustments. The guideline strives to promote, for regulators
(assessors and inspectors), an improved understanding of the Applicants'
pharmaceutical quality systems (PQSs) for management of post-approval CMC
changes. This new guideline is intended to complement the existing ICH Q8 to
Q11 guidelines.
For
details, see: https://www.ema.europa.eu/en/ich-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-managementPosted by Dr. Tim Sandle, Pharmaceutical Microbiology
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