Disqualification of testing facilities

Subpart K (FDA only) Disqualification of Testing Facilities We now take a look at each subpart individually. 

Subpart K of the FDA regulations discusses the grounds for the disqualification of testing facilities, the procedures and actions associated with disqualification, and the procedure for the reinstatement of disqualified facilities. 

Disqualification of testing facilities Disqualification Suspensions or terminations Reinstatement... 

The FDA regulations end with a discussion of procedures for Disqualification of Test Facilities (subpart K). 

Public disclosure of information regarding disqualification Alternative or additional actions to disqualification Suspension or termination of a testing facility by a sponsor Reinstatement of a disqualified testing facility... 

Public Disclosure of Information Regarding Disqualification 58.215 Alternatives or Additional Actions to Disqualification 58.217 Suspension or Termination of a Testing Facility by a Sponsor 58.219 Reinstatement of a Disqualified Testing Facility... 

Numerous comments were made on the provisions for disqualification of a testing facility (subpart K). Although the proposal stated that the agency considered that it would only rarely invoke this penalty, it appeared from the objections that industry had interpreted these provisions to mean the agency would invoke disqualification frequently and for minor failures to comply with the regulations. On the basis of the objections, the sections of subpart K on purpose ( 58.200) and the grounds for disqualification ( 58.202) were extensively revised. The revision stated that the purposes of dis-quahfication were as follows ... 

Care should be taken in the preparation of the conforming amendments statements. While failure to comply with GLPs is only subject to administrative sanctions (e.g., disallowance of a study or disqualification of a testing facility), knowingly submitting a false statement to the FDA is a criminal offense punishable by fine and/or imprisonment. 

The FDA may find that it needs to disqualify testing facilities if the facility has not complied with the requirements of the GLP regulations. All studies completed after the date of disqualification can be excluded from consideration. It is prudent to ensure that all laboratories used are GLP compliant, or studies and entire projects may be compromised. 

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