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Every year, the FDA publishes a Guidance Agenda. It lists documents that
the FDA
intends to publish in the next fiscal year.
This year's list includes a number of interesting initiatives:
In the field of biologics (CBER):
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Design, Operation, and Validation of Heating, Ventilation, and Air
Conditioning (HVAC) Systems Used in the Manufacture of Products
Regulated by the Center for Biologics Evaluation and Research and the
Center for Drug Evaluation and Research.
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Validation of Rapid Microbiological Methods for Assessing Sterility
of Cellular and Gene Therapy Products.
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Characterization and Qualification of Cell Substrates and Other
Biological Starting Materials for the Production of Viral Vaccines.
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Changes to an Approved Application: Biological Products.
In the field of veterinary drug products (CVM):
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Chemistry, Manufacturing, and Control Changes to an Approved NADA or
ANADA.
In the field of drug products/chemistry (CDER):
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Quality by Design.
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Process Validation: General Principles and Practices.
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Penicillin as Defined in the CGMP Regulation under 21 CFR 211 and
Separation Requirements for Manufacturing.
What will certainly also be interesting is the Guidance "Importation of
Active Pharmaceutical Ingredients". Another remarkable fact is
that the FDA plans to issue a guidance on Quality by Design. Since
documents that are being harmonised through the ICH process are marked in
the list, it seems as though the FDA wanted to publish a guidance in
addition to the document ICH Q8.
The pharmaceutical industry has been waiting a long time for the review
of the guidance on process validation: general principles and practices.
Now that the corresponding Compliance Policy Guide (CPG) has been adapted, this
document is overdue. According to the information in hand, the guide
will continue the new risk-based implementation (among other things
waiving the 3 magic validation runs) in a consistent way.
On the whole, one can say that the FDA stays on the course of the cGMP
for the 21st Century Initiative (http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm).
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