About GxP Perspectives


GxP Perspectives

The Blog for Working GxP Professionals

This blog seeks to talk about issues of importance to the Food and Drug Administration, regulatory compliance, and GxP best practice. It is meant for those of us who work in the life sciences as GxP professionals, particularly quality assurance professionals but hopefully it has information of interest to the general public.

It is told from the perspective of Carl Anderson, a Tacoma, WA based regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. There are also a number of contributions by other GxP professionals. Please see the Guest Commentaries page for more information.

About the editor:

From 1987 to 2005 Carl worked for the United States Food and Drug Administration. In 1994 Carl began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research. He was on the FDA’s international inspection cadre and has conducted audits and inspections in Canada, Europe, the Middle East, and East Asia.

GxP Perspectives

Carl Anderson
Regulatory Compliance Consultant

Since leaving FDA Carl has done well and had fun. He is currently not accepting new clients and recommends some of the Guest Contributers who have written for the blog the past few years.

Carl’s email is: carl11anderson@yahoo.com

GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives

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7 Responses to About GxP Perspectives

  1. Monte says:

    Carl – an outstanding and useful blog, that may become part of the culture-change that could enhance the public view of the importance of public service agencies. Leadership and expertise could make government agencies hopeful of doing some good again, and be a part of attracting a new generation of public servants.

    In these days of “government is bad” cynicism, many give up making government better, which puts it on a downward spiral.

    Thanks for using your voice to pull in the other direction.

  2. mark savage says:

    Great blog, Carl. A friend who is an ENT doctor is considering purchasing a cold laser, class IV, to see if she can shrink solid tumors. The device is labelled for pain mgt and blood flow stimulation only. Do you have any insight on this type of situation or can you point me in a direction? thanks.

  3. Cen Zhenhan says:

    Dear Carl, I was trained in UW & DOPH in Seattle, and now QA in an Asian Clinical Trial Site (a large hospital). I was trained and used the 21 CFR 312,50, others routinely in my audits. Until I was “told off” by commercial sponsors’ (at least 2 and they are part of the global top 10s) QA Directors, to me -“lay off”: “QAU of Sites cannot audit commercial sponsors’ clinical trial” because ICH E6: 5.19.2 (a)said : “they must appoint me”. “Me” as in Site’s QAU (by GLP 21CFR 58-compliance, we also have Bioequivalence Studies here). Are these commercial sponsor QA directors correct in their use of ICH E6: Section 5 “Sponsors” obligations for Clinical Trial conduct in multicenter studies (in Asia, like mine, and Latin America and Australia)? They (QA directors of local affiliates of global Top 10 pharmaceutical companies) also cited confidential issues with respect to their Protocol Agreement parties – investigator (of our site); CRC (where I am based in the QAU) or hospital (our site, and CRC is located) and the Commercial Sponsors. They said the Investigator must “re-approve” our CRC-QAU’s participation in our Internal Audits, else “lay-off” their protocols and trials! We got a VAI from US FDA inspection as a result of this “lay-off” policy here! Are they correct in ICH interpretation?

    Hope to hear a comment from you. A member of the BARQA. MPH(Seattle)

    • GxP Perspectives says:

      An interesting problem. FDA regulates by sponsor and investigator, not the hospital. So technically the investigator should approve of your audits. However, your institution certainly has a right to require their investigators to participate in your quality assurance program including internal audits. So the “re-approval” should be a requirement of the institution. Part 58 does not apply in your case. It is for nonclinical studies only (GLP).

  4. George Orr says:

    Carl,

    I am not sure the best place to post this question: I work in Medical Oncology Research and I have been noticing what I feel to be a distubing trend in manditory tumor tissue submission. In the past, studies required tissue samples if they were needed to determine eligibility or randomization to a treatment arm (Essentially something that was a potential benefit to the patient or needed to deterimne if study endpoints were met). Those studies usually gave patients the option to allow the sponsor to keep archived tissue for “future testing” that had no benefit to the patient or current study. Recently, some sponsors have been requiring this “archived tissue” as part of the inclusion / exclusion criteria – “If you don’t give us the tissue, you can’t go on our study.” Do you know if anyone is discussing this issue or is concerned how this may impact patient rights?

    • GxP Perspectives says:

      I am posting this comment on the GxP Perspectives LinkedIn group where we may have the appropriate subject matter expert

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