Following processes and operations needs to be put on highest vigil to find out early any occurrences of non compliance which can lead to failure of lab related investigation and subsequent warning letter and finally disqualification of laboratories.
1. Generally observed criteria for disqualification
. Testing facility failed to comply with GLP
. Noncompliance adversely affecting study validity
. Other regulatory actions not effective
2. Steps followed after non-compliance is observed in a laboratory
. Warning letter – The letter typically addresses issues like failure to maintain equipment quality, malpractice or malfunction of equipments, failure to write and follow adequate procedures for maintenance and cleaning and also issues like failure to prepare Master Production and Control Records and other observed discrepancies.
In case of failure to rectify the discrepancies mentioned in the warning letter, next step is –
. Disqualification – While disqualifying a facility, the FDA Commissioner specifies the reasons in a letter addressed to the top management of the facility, which are commonly:
– The testing facility failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter);
– The noncompliance adversely affected the validity of the nonclinical laboratory studies; and
– Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not been or will probably not be adequate to achieve compliance with the good laboratory practice regulations.
Usually, the facility receives an opportunity of hearing.
1. Whenever the Commissioner has information indicating that grounds exist under Sec. 58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified.
2. A hearing on the disqualification shall be conducted in accordance with the requirements for a regulatory hearing set forth in part 16 of this chapter.
Finally, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, makes the findings required in Sec. 58.202, the Commissioner issues final order for disqualification
