In April 2005, Jay Eltermann, CBER/FDA, gave a very comprehensive talk on
recent FDA developments with regard to inspections and regulations for
biologics.
His presentation provided a good insight into current inspection trends
of FDA.
Part of the first section is a list of topics that regularly cause
problems during reviews:
- Validation issues
- Insufficient information
- Product comparability
- Stability
In general, Jay Eltermann notices significant differences depending on
the level of experience a firm has. Experienced firms frequently face
problems with following existing systems and evaluating the impact of
process changes on product quality. "First-timers" often have
incomplete quality systems and procedures, incomplete documentation and
incomplete equipment qualification and process validation.
In the second part of the presentation, you will find a considerable
number of slides that give an overview of typical inspection topics
concerning:
- Facilities
- Multi-product issues
- Personnel
- Process
- Quality unit
- Contract manufacturing
Jay Eltermann's concluding recommendations are: to keep up with the
latest inspection trends and regulatory initiatives and to have meetings
with FDA at critical points during the process or when major changes are
anticipated.
This statement leads to the last part of the talk, which reflects on
the most important regulatory initiative of FDA:
- cGMP for the 21st Century
- Critical path
- Efficient risk management
The presentation ends with a table of those challenges that cause
approval delays in many cases:
- Process validation
- Manufacturing consistency
- Equipment and systems qualification
- Quality oversight
- SOPs
Jay Eltermann's presentation is of great benefit to you if you would
like to get an overview of FDA's current thinking and acting concerning
biologics.
You can download the slides here.
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