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The Pharmaceutical Quality for the 21st Century – A
Risked Based Approach is FDA’s effort to enhance and
modernize the regulation of pharmaceutical manufacturing and
product quality — to bring a 21st century focus to this
critical FDA responsibility. The initiative is intended
to modernize FDA’s regulation of pharmaceutical quality
for veterinary and human drugs and select human biological
products such as vaccines. As part of this initiative,
both the pharmaceutical, as well as the chemistry, manufacturing,
and controls (CMC) regulatory programs were evaluated with
the following objectives in mind. The Initiatives efforts
are carried out by the Agency’s Council on Pharmaceutical
Quality (CPQ)
- Staff Manual Guide
- CPQ Workgroups
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