Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 13 Issue 2 - Page 1 - Fall/Summer 2010
TIDS AND BITS
I am down to two hard copy newsletters a year. I am doing email updates to those who are on my email list. So, if you want to be on the email list, please let me know. I am not sure how much longer it is really feasible to do paper newsletters (but at least it supports the local post office). Although SQA was held back in April, many people couldn’t attend and even for those who did a recap of some items might be beneficial.
- EPA Update (by Francisca Liem – The same issues that have been
the high level compliance issues for EPA are still occurring. Highlights
of her presentation include:
There were 82 EPA inspections conducted in FY 2009 with 67%
resulting in no findings and 82% with no high level violations. Findings
included:
- • Management serving as the SD
• QAU actively involved in study conduct
• QA approves SOPs
• Study has 2 study directors
• Sponsor writes the final report
• Sponsor changed the final report after it was signed
- • Management serving as the SD
The US has MAD agreements with OECD member countries. If you are in compliance with EPA GLPs, you do not need to reference OECD in your protocols. The data will be accepted.
However, if a US lab has not been inspected by EPA, the study will not be accepted by other OECD member countries.
Sponsors must assume an active role in confirming that all studies were conducted in compliance with GLP. The Sponsor should not rely solely on assurance of the testing facility. The Sponsor is signing the compliance statement when studies are submitted, so they must be sure they are signing a true compliance statement. EPA is concerned with fraud. QA should help alert management of potential fraud and be able to differentiate between simple mistakes and red flags.
On the FDA side, Dr.. James McCormack (President of SQA) provided the FDA Update based on information received through FOI. Of concern to all was the fact that FDA only conducted 34 GLP inspections last year. We did not receive any metrics as we have in the past (these are not available through FOI).
We were informed that FDA will be issuing a notice asking for public comment regarding a possible revision of the GLPs. The notice was expected to be issued in the Federal Register in June but has not yet been published. Evidently, it is still hung up in clearance and OMB wants to review it. I asked Dr. Jean Toth-Allen just recently for an update and here is a portion of her reply:
When it does issue (the GLP notice), we - the Office of Good Clinical Practice (OGCP) in the Office of the Commissioner - will send a listserv notice announcing its availability. If you have not already signed up for such notices from our website. you may find it useful for you and your colleagues to do so. While our site is mainly concerned with clinical trials, since our office director is the chair of the Human Subject Protection/Bioresearch Monitoring (HSP/BIMO) Council, we are also involved with all areas of research covered by the agency's bioresearch monitoring program, which obviously includes nonclinical/ GLP studies. You will therefore find links to pertinent GLP regulations and guidance documents on our site as well.
CDRH just issued a new guidance - Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices
West Coast Quality Training Institute
2010 Fall Training Schedule
Hood River, OR
- GLP 101 - October 19, 2010
- GLPs for Study Directors and Monitors - October 20th and 21st
- GLPs in the Real World- October 26th and 27th
Baltimore, MD – GLP Triple Play - Sept 28-30
- Old GLPs in a Brave New World (advanced Issues) Sept 28
Debi Garvin (debi@pacrimqa.com)
- Validation and Part 11 Sept 29
Monica Cahilly (mcahilly@gmqa.net)
- Bioanalytical Validation, Issues and Updates Sept 30
Dr. Chris Tudan (bioaccurate@gmail.com)