Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 11 Issue 2 - Summer 2008
TIDS AND BITS
The SQA annual meeting last April in Memphis was widely attended. There were many very good sessions with CVM reviewers and also BIMO personnel giving some excellent tips for submissions and data quality. Both EPA and FDA presented their annual updates and highlights. I have summarized these below.
FDA UPDATE
Dr. Jackie O Shaughnessy from DSI presented the update for Dr. Viswanathan, who could not attend. Across all centers the overall classification for 2007 inspections were 36% NAI, 59% VAI and 5% OAI. The NAIs have significantly decreased, while the number of VAIs has increased substantially. Other issues include:
Test arcticles
No C of A on the actual batch used in the study Stability data was not provided by the Sponsor and the impact was not addressed in the final reportProper storage of test articles was not assured.
Dosing
- Target dose was not assured
- Infusion pumps failed calibration
- Stirring of dose formulation was not documented
- No homogeneity data available
- Dose formulation concentration uniformity or stability was not determined
- Test Article characterization was not obtained from the sponsor
- Concentration analysis was done by the Sponsor and reported separately
Study Drector
Bioanalytical method integrity was not demonstrated - Inadequate documentation of sample handling - Final reports lacked signed and dated contributing scientists - reports Final report did not name the Contributing Scientists
Q and A
Outsourced phases lack adequate oversight SD and management were not immediately informed of circumstances that may have affected data integrity
Archives
Required timeframe for archiving not met
Protocols were not archived
Access to archives not controlled
EPA UPDATE
Francesca Liem presented the EPA Update. In 2007, a total of 96 inspections were conducted. Of these, 76 were closed and 20 referred for enforcement. The findings presented were along the same lines as previous years, but then Francesca presented us with a pleasant surprise by issuing a “GLP Alert”, as follows:
- AOAC validated methods have to be revalidated under GLP
- Test substance in a mixture has to be analyzed with an appropriate, correct and reliable method
- Do not put non-compliant procedures in the protocol. If you do, you still must list them in the compliance statement
- Sponsors and the Testing Facility must maintain a copy of the Final Study Report and amendments
- Although GLPs allow true and accurate copies of raw data, FIFRA requires original be maintained
- A PDF copy of the final report has to be ascertained that it is a true and accurate copy of the original
- Feed, drinking water, and soil must be analyzed for possible contaminants
- The Compliance statement must be signed by the Study Director, Sponsor and Submitter
- Facilities no longer conducting GLP studies must notify EPA
- If your organization is not directly involved in the conduct of a study, do not list it as a performing laboratory
- If there is a change in a laboratories name or ownership, EPA must be notified
- Periodic status reports MUST be submitted to the SD and management – simply sending the actual inspection reports does not meet this requirement.
Exciting New Training Opportunity
Plans are being made for a three day GLP/GCP training course to be held in the Boston area late March 2009. Monica Cahilly, a well known validation and Part 11 expert, will be presenting an entire day on Part 11 and validation; Dr. Chris Tudan will be presenting another day on bioanalytical technical issues, and I will be addressing various GLP topics. Additional details to follow.