New testing facility guide replaces inspection checklist.

FDA has released a new guidance on the inspection of viral marker testing facilities, which could give inspectors more flexibility in writing up citations on HIV and other disease testing of blood.

The new Guide for Inspections of Viral Test Marker Facilities is part of a series of manuals that replace the Form 2609 checklist system.

Investigator Denise Dion, Office of Regulatory Affairs, Division of Emergency and Investigational Operations, Investigations Branch, said in interview, "We decided in consultation with CBER to do away with the checklist....ORA didn't think it gave enough flexibility. It didn't let them focus on the most important things done at that facility. By removing the checklist, you let investigators get in and do more focused inspections."

FDA already has published a Guide to Inspections of Blood Banks and Guide to Inspections of Source Plasma Establishments. Dion explained that the viral marker testing document can be used by investigators as needed in conjunction with either of these documents.

A fourth guide, covering blood bank software, is also in the works, according to Dion, but will not be released until a similar, complementary document is available to industry.

Describing the new guides, Dion said they cover the same territory as the old checklist, but with the science updated.

'Prompt' reporting still awaits definition

The guide addresses reporting of errors and accidents, saying this should occur "promptly" -- a word that has caused industry some interpretational headaches. But, instead of defining the term, the guide says that FDA awaits clarification "based upon a recommendation in an Inspector General's report" and refers questions on the subject to the Division of Inspections and Surveillance.

The document gives examples of incidents that may affect a product's "safety, purity, or potency" and provides guidance for evaluating the seriousness of an error.

The guide tells investigators how to look at such procedures as the receipt and tracking of samples, testing specifications and written agreements between blood establishments and contract labs.

Investigators are directed to make sure Standard Operating Pocedures match test kit manufacturer's instructions. While calling incubation time important, it says "slight variances have been taken into account by manufacturers."

Other areas include facilities, equipment, personnel training, scientific principles, viral marker and infectious disease testing, radioimmunoassays, records, disposition of units with reactive test results, infectious waste and biosafety.

In this last category, the guide says that SOPs should be in line with recommendations from the Centers for Disease Control and OSHA.

Copies of the Guide to Inspections of Infectious Disease Marker Testing Facilities (Doc. 107545M) are available for $5 plus handling.