What to Know About Cytogenetic Labs and GCLP Standards
In the field of cytogenetic lab testing, operating by the highest standards can make all the difference to the success of your business. The Good Clinical Laboratory Practices (GCLP) is one of several accepted set of standards that guide implementation of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).
The emergence of GCLP standards coincided with the merging of GLP with GCP into a single set of regulatory standards designed to bring greater accuracy and accountability to the rapidly growing sphere of medical testing facilities. GCLP is unique in that it borrows QC elements from GLP and ethical elements and scientific standards from GCP. According to the Global Health Network, the combined standard “ensures the quality and reliability of the clinical trial data generated by laboratories.”
GCLP standards touch on all areas of clinical laboratory operations, including standard operating procedures, equipment and materials handling, workflow planning, subcontracting, quality control and quality audits, records storage, confidentiality, personnel and facilities management, as well as some additional aspects of the laboratory environment. Implementation of GCLP standards is overseen by the Department of Health and Human Services (DHS) with supplemental documentation provided by the Food and Drug Administration (FDA). Due, however, to certain ambiguities in the text of the GCLP regulations related to intent, other accrediting agencies, such as the International Organization for Standardization (ISO) or the College of American Pathologists (CAP), may provide guidance on a range of issues.
In 2011, a coalition of government agencies including the National Institute of Allergy and Infectious Diseases, US National Institutes of Health created the ‘Division of Acquired Immunodeficiency Syndrome (DAIDS) Guidelines for Good Clinical Laboratory Practice Standards,’ which apply to testing facilities participating in DAIDS-funded clinical trials.
The GCLP standards certification process requires both lab personnel to receive specialized training and for their lab to receive a strategic assessment, assuring regulators of the quality, reliability, and integrity of results produced.
Outsourcing your cytogenetic testing is also a very common industry practice. Virtual Scientific can save your business valuable time and money by conducting your cytogenetic testing needs. Our laboratories and technologists have all the certifications and accreditations mentioned in the article above so that your workflow can stay intact, no matter the testing application. Virtual Scientific clients benefit from our industry-leading TAT, and our highly experienced cytogenetic technologists integrate into your team seamlessly, adapting easily to different analysis protocols.