Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 12 Issue 1 - Page 1 - Summer 2009
TIDS AND BITS
GLP TRIPLE PLAY Nov 2-4 - South San Francisco,CA
You’ve asked, we have delivered and are repeating Triple Play!!! Join us for one to three days of intense GLP/GCP training focusing on all the latest hot topics in our industry. Three leading experts have gotten together to share their knowledge, insights and experiences. Day 1 will be facilitated by Debi Garvin MS RQAP-GLP and will include the latest GLP issues such as managing multi-site studies, monitoring contractors, developing protocols that mitigate and minimize risks when conducting multi-site studies and the latest issues/findings of FDA investigators. Monica Cahilly MS RQAP-GLP, a leading expert in Part 11 and Computer Systems Validation, will host Day 2 and discuss latest standards, such as Red Apple II, as well as current regulatory trends, including the increasing focus on electronic data integrity, presenting in-depth but understandable solutions to these issues. And finally on Day 3, Chris Tudan Ph.D. shares his in-depth knowledge in the field of bioanalytical chemistry. Chris incorporates current guidance’s, industrial standards and white papers in presenting a very technical overview of regulatory requirements in method validations and sample analysis. He will detail method development/validation considerations to ensure robust and compliant sample analysis for both clinical and GLP studies. Attendees may register for 1 -3 days, with discounts given for multiple days. See registration form enclosed for fee structure.
Regulatory Update
Based on various presentations throughout the year, there appears to be some severe compliance issues within both the FDA and EPA regulated communities. I will summarize some of these below:
The electronic file is the raw data, period. Companies cannot define the paper records as raw data. Items observed include:
- Redrawing baselines for standards and QCs to make runs pass, scaling down the chromatogram, printing it and then deleting the electronic file.
- Redrawing baselines to make a standard fail, which allows it to be deleted, or rejecting good standards. Once the standard is deleted, failing QCs now pass.
- Redrawing baselines for product release until impurities are below acceptable levels. Again, once the chromatograms are scaled down and printed (making the baseline next to impossible to see), the file is printed and the electronic file discarded.
QA inspection reports must be sent to the Study Director and TFM in a timely manner.
FDA is still working on modernization of GLPs. The FDA has a working group in place and has received feedback from shareholders.
Any study that contains PK/TK data submitted to FDA must address ISR. For clinical, the number depends on the size of the study; for GLP, good judgment should be used; but once ISR has been determined for a matrix and species (GLP), it does not appear it needs to be repeated for every study. A whitepaper on ISR was issued in April.
Both agencies have stressed the fact that correspondence in the form of emails and phone logs must be retained and archived as part of the study files.
The Study Director must be the single point of control and qualified to run the study. Numerous compliance issues have been cited concerning the Study Director, including:
- Lack of adequate characterization data
- Lack of dose formulation data
- SD not being made aware of unforeseen circumstances at all sites
- SD has not authorized deviations at all sites
- SD has not received QA inspections from all sites in a timely manner
- Lack of oversight by the SD and QA at outsourced facilities
- SD did not have adequate education, experience and training to run the study.
West Coast Quality Training Institute
2009 Training Schedule
Hood River, OR
- GLPs for Scientists and Technical Staff - Oct 1st and 2nd
- GLPs 101 - Oct 13th
- GLPs for Study Directors and Monitors - Oct 14th and 15th
- QA Audits, Inspections and Responsibilities - Oct 21st and 22nd
South San Francisco, CA
- GLP TRIPLE PLAY - Nov 2nd thru 4th