Purpose
Disqualification may serve the following purposes:
1. To exclude from being considered the completed studies
that were performed by a facility that has failed to comply with GLP
regulations until it can be proved that such non-compliances did not occur
during a particular study or that the non-compliances did not affect the
acceptability of data generated during that study.
2. To exclude from being considered, all the studies that
have been completed following disqualification until the facility undertakes to
conduct studies according to GLP regulations.
If a testing facility is disqualified, the sponsor of the
study that was performed (and disqualified) cannot use that as an excuse to not
submit the study in their application for a research or marketing permit. They
must get the study repeated and submit it with the application.
Disqualification Grounds
Reasons why a testing facility may be disqualified include:
• Failure to comply with one or more of the GLP regulations.
• The non-compliance has created an adverse effect on the
validity of the study.
• Previous incidents of warnings or individual study
rejections have not helped to achieve compliance with GLP guidelines.
When the FDA has relevant information to justify a test
facility disqualification, the Commissioner issues a written notice to the
concerned facility proposing the disqualification. A regulatory hearing will
then be conducted as per legal guidelines.
Final Disqualification Order
After the regulatory hearing, or after the time permitted
for a contest by the facility passes without such action, the Commissioner of
FDA evaluates the records of the proceedings and issues the final order to
disqualify the facility, with the reason for the disqualification. A copy of
this order must be sent to the testing facility.
Actions Following Disqualification
After the disqualification of a testing facility, scrutiny
is done of every application for research or marketing permit that contains
data from a study conducted by the disqualified testing facility. It is
determined if that study is acceptable or not. If the study is considered unacceptable,
the onus lies on the study sponsor to prove that the study was unaffected by
the non-compliance that led to the disqualification. This may include
validating the data by a repeat study.
Any study done by a disqualified testing facility will be
invalid for the purpose of application for a research or marketing permit
unless the facility has been reinstated after due procedure.
Public Disclosure of Disqualification
After a testing facility has been disqualified by the final
order, the FDA Commissioner notifies all interested persons at his discretion
if he believes the disclosure is in the public interest, or that it will
promote compliance with GLP. If public notice is given, it must include a copy
of the final disqualification order along with the statement that the FDA will
not consider any studies done by the said facility in support of any
application for research or marketing permit.
Termination or Suspension of Testing Facility by Sponsor
If a sponsor suspends or terminates a laboratory from
further participation in the study, it must notify the FDA in writing within 15
working days, along with the reasons for such action.
Reinstatement of a Disqualified Testing Facility
The disqualified testing facility may apply to the FDA
Commissioner assuring that it will comply with GLP regulations in the future,
along with details of the corrective actions that have been taken or are
intended to be taken, and the reasons why it believes it must be reinstated. On
examining this submission, and following an inspection, if the Commissioner
determines that GLP regulations are being followed, he may reinstate the
testing facility as a source for the study. The testing facility must be notified
and any other involved persons, such as the sponsor, and information about the
reinstatement must be publicly disclosed.
Before a new drug is introduced into the market, it has to
undergo certain in-vitro and in-vivo experiments in a non-clinical setting.
This is usually achieved through a study that involves testing of the drug on
animal specimens, or microbiological or biological test systems. For the
results of such studies to be valid and authentic, the study must have been
conducted under conditions that ensure data validity and integrity. GLP
guidelines provide information regarding these conditions to be maintained by
testing facilities and complying with these is the key to a successful application
for a new drug.