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FDA
21 CFR 1271 Regulations
As
one studies the regulations closer, as well as studying the results of
early inspections, it becomes clear that FDA
compliance is a much more complex issue than many in the reproductive
medicine industry initially realized.
Inspections during the first year, were mainly educational in
scope, however, it is clear that the intensity of the inspection process
is increasing, as evidenced by the number of form 483s which have been
issued, not to mention one IVF facility receiving a warning letter.
What
we have learned at this point is that the three most important items to
meet and maintain FDA compliance are documentation, documentation, and
documentation,
not unlike the three most important rules in Real Estate being location,
location, and location.
As
reported by the FDA at the September, 2006 Annual Meeting of the American
Association of Tissue Banks: A
total of 27% of reproductive facility inspections resulted in observations
and the issuance of a Form 483. The following were among those observed
areas of non-compliance;
- SOPs
for screening and testing were not established and maintained.
- SOPs
for screening of donor eligibility were not followed.
- Documentation
of donor screening for communicable diseases was not maintained.
- Eligibility
of an HCT/P donor was not documented by a responsible person based on
results of donor screening and testing.
- Communicable
disease testing is incomplete (CMV, HIV-2, Chlamydia not tested).
- Donor
specimens used for testing communicable disease agents were not
collected at the appropriate time.
- Distribution
of gametes from donors residing in countries where there is a CJD/vCJD
risk identified.
- Embryo
donation where a 3rd party gamete donor used
- Release
of embryos where there were problems in donor eligibility.
- Donor
Eligibility and gestational carriers
This means that every clinic must have a well-designed and well-documented
Standard Operating Procedure Manual.
This manual must cover all aspects of the donor eligibility
determination, and those procedures must be followed.
ReproTech,
Ltd, has a long history of utilizing FDA compliant styled SOPs, due to the
hiring of a Quality Assurance officer from the Medical Devices industry
many years ago. We understand the multiple layers involved in the development of an
effective Standard Operating Procedures plan.
Furthermore, ReproTech’s principals each have extensive donor
program experience and work closely with Reglera,
an FDA compliance consulting firm.
Reglera
and ReproTech have worked together to develop services and products which
can help bring your clinic into compliance quickly. Our Donor Egg
Eligibility SOP package has been available for two years, and we recently teamed
together to develop the first of its kind, automated, web-accessible
system, Electronic
Donor Eligibility, to assist
in the donor eligibility determination process. This system is
specifically designed to provide IVF facilities with
the ability to fully automate the donor eligibility process in a way that
is not only compliant with FDA 21 CFR 1271,
but also speeds up eligibility determination and saves money.
Most
clinics have neither the time nor the staff to maintain full FDA
compliance utilizing only clinic staff.
ReproTech and Reglera are available to help. To receive
a free FDA booklet or for more information on our FDA Compliance services,
contact either ReproTech at 888-489-8944 or Reglera at 800-541-4255
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