New testing facility guide replaces inspection checklist.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. 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 The Office of Regulatory Affairs (ORA) is the part of the United States FDA that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates. , Division of Emergency and Investigational Operations, Investigations Branch, said in interview, "We decided in consultation with CBER CB·er
One that uses a CB radio. to do away with the checklist....ORA ora (o´rah) pl. o´rae [L.] an edge or margin.
ora serra´ta re´tinae the zigzag margin of the retina of the eye. 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 as needed prn. See prn order. in conjunction with either of these documents.
A fourth guide, covering blood bank software, is also in the works, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. 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 Infectious disease
A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. 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 OSHA
Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace. .
Copies of the Guide to Inspections of Infectious Disease Marker Testing Facilities (Doc. 107545M) are available for $5 plus handling.