As an auditor who has audited and supported regulated studies on behalf of the sponsor around the globe, and past associated director of two bioanalytical laboratories, it was very apparent to me that there was a gap in knowledge of the applications of the Good Clinical Practices (GCPs) in the bioanalytical laboratory. Moreover, at a Society of Quality Assurance meeting, I teamed up with two other speakers to discuss the topic to a packed conference room. The lack of awareness of how to apply the GCPs to the bioanalytical laboratory is in part a reflection of the fact that the FDA has not provided a respective guidance. The FDA simply states in the recently published ICH M10 bioanalytical guidance that it was necessary to follow the GCPs in the laboratory. But what aspects of the GCPS are applicable to the bioanalytical laboratory? That is what I set out to describe in an article that we just E-published in the Bioanalysis journal, which will also be in print on November 2, 2023. Experience has taught us that since there is currently no guidance in the United States pertaining to the applications of the GCPs in the bioanalytical laboratory. Rather, risks are made at bioanalytical laboratories throughout the industry with no harmonized approach available to enable GCP compliance, data integrity or patient safety in the laboratory. It is our hope that this comprehensive article titled: Good Clinical Practices in the Bioanalytical Laboratory, will shed light on what parts of the GCPs are applicable to the bioanalytical laboratory, which can also be incorporated into your SOPs. Some of the key applicable aspects of the GCPs include the fact that the sponsor can transfer any or all of the sponsor’s trial-related duties and functions to a contract research organization (CRO). The sponsor/CRO arrangement must be prescribed in writing, and the ultimate responsibility for the quality and integrity of the trial data, including the bioanalytical data, still resides with the sponsor. Moreover, it is expected that the bioanalytical laboratory will support facility and study audits of the various trial facilities. Audits of the facilities, according to the GCPs, are necessary to ensure that the trial has oversight measures that should be fit-for-purpose and tailored to the complexity of and risks associated with the trial. My article breaks out into eleven sections of what aspects of the GCPs are applicable to the laboratory. Also, my article delves into such notions as the responsibility for investigational product(s), accountability at the various trial sites and laboratory(s) rests with the investigator /institution/bioanalytical laboratory. Additionally, to protect patient confidentiality, clinical samples must be labeled in such a manner that a subjects’ identity cannot be identified. We invite you to review the article, which can be accessed at: https://tinyurl.com/mryvb6c8, to learn more of the aspects of the GCPs that are applicable to the bioanalytical laboratory. Should you have any questions or want more information on how Veloxity Labs can deliver your bioanalytical needs with defendable quality and speed, please contact us at info@veloxitylabs.com.
Director of Quality
Chris Tudan, Ph.D.