Page 1 - Page 2 - Page 3

Pacific Rim Consulting, Inc. - NEWSLETTER

Volume 15 Issue 1 - Page 1 - Winter/Spring 2012

Page 1 - Page 2 - Page 3


Although I keep saying I am going all electronic, I just have not been able to completely pull the plug on the paper newsletter. Many of you have asked to be added to the electronic distributions and you have, but I might not have taken you off the paper mailing list. The advantage of being on my electronic distribution list is that, in addition to receiving electronic newsletters, I also email regulatory updates as they occur. Although not much is happening in the GLP arena, there are a few items that might be of interest to some of you.

  • As already known, EPA is down to a staff of 4 inspectors. In accordance with the various MOU and MAD agreements, EPA must inspect and find the laboratories in compliance with GLP in order for the studies to be accepted internationally. Unfortunately, EPA has not been able to conduct inspections of all facilities in the US and the EU has both rejected studies and suspended approving registrations based on studies conducted by labs not inspected recently by EPA. In addition, one particular lab actually closed in 2009 and had never undergone an EPA inspection, leading to the EU rejecting the study. Due to current US budget constraints, it is highly doubtful that the EPA GLP inspection program will get additional funding. Infrequent inspections coupled with laboratories opening and closing without ever having been inspected by EPA create a huge problem for US laboratories and Sponsors. The regulated community must come up with some solutions. I have suggested a couple options in the past (based on the very early SQA laboratory certification committee and personal experience). My solutions are as follows:
  • Laboratories conducting GLP research in support of EPA registrations would register with the agency and receive a “registration number” prior to conducting studies. The registration process would require submitting key documents (floor plan, organizational chart, job descriptions, SOP index, Master Schedule, and critical SOPs) that support GLP compliance, along with CVs of key personnel, including QA, TFM and SDs/PIs.
  • Sponsors would be responsible for assuring compliance of their contractors through inspections and audits, submit to the agency a list of all facilities inspected each year and attest to the compliance of the facilities they are using. Please note that Sponsors already are held liable for compliance of their studies through compliance statements.
  • EPA inspectors would then focus on the major contractors, studies with data issues, directed audits, and Sponsors.
  • I also think the EPA inspection program should be imbedded into OPPTS and supported with a portion of the user fees.

Similar issues arise with all GLP facilities in the US, as neither agency inspects a facility until data are submitted. A facility registration program (which would assure all laboratories submitting data have an actual GLP program in place), combined with a user-fee supported inspection program should alleviate many of the problems. See page two for my thoughts on the OECD process.

FDA is busy working through the comments received in December 2011 regarding modernization of GLPs. They have addressed about 25% of the comments and plan to have the proposed regulation published in February 2013. Most of the comments from the December notice will be addressed in the February 2013 proposed rule, with all comments being addressed by publication of a final rule. While a lot of the issues are simple, it appears that FDA is struggling with how to adequately address current issues such as contributing scientist reports and drafts, pathology peer review and transparency of Sponsor involvement.


A full day of biotechnology related to Crop Science and GMOs will be presented in Miami at the SQA meeting in April 2012. The first session will include requirements of the various agencies (EPA, FDA, USDA) as well as international requirements. The second session will focus on molecular and protein characterization as well as EPA inspections of Biotech laboratories. The third session is a panel discussion, with the morning speakers addressing the “hot topic” issues faced by Crop biotech companies (e.g. what is a study, what is the test substance, when is the experimental start date, etc.). The day will wrap up with an EPA presentation of updates, trends and findings. Regulatory speakers have been invited.

West Coast Quality Training Institute

2011 Winter/Summer Training Schedule

Hood River, OR

  • GLP 101 - October 16
  • GLPs for Study Directors and Monitors - October 17,18
  • Quality Assurance Audits and Inspections - October 24-25