Pacific Rim Consulting, Inc. - NEWSLETTER
Volume 13 Issue 1 - Page 1 - Winter/Spring 2010
TIDS AND BITS
It may appear that these newsletters are becoming less and less frequent (they are!). It is not necessarily the fact that there is no news, but rather most regulatory news spreads like wildfire over the internet, so by the time these newsletters come out, it may be “old news”. A few items that some of you may not be aware of:
- Over the past ten years FDA injunctions fell from a high of 22 in
2003 to a low of six in 2008. Warning letters fell from a high of
1154 in 2001 to a low of 445 in 2008.
- Based on an FDA presentation in November 2009, the agency has determined that increased enforcement is necessary. Parts of this initiative include:
- Post inspection deadlines: FDA expects a prompt
industry response to significant findings - no more
than 15 days OR FDA will issue a Warning Letter; the
response to the 483 must address all findings. As
such, FDA will issue WLs more timely and facilitate
prompt corrective action.
- FDA will speed issuance of Warning Letters, and limit
Chief Counsel review to “significant legal issues”.
This will streamline the review process consistent
with historical practice.
- FDA will work with regulatory partners to develop
effective risk control and enforcement strategies. This
includes use of local, state and international
authorities for quicker action. Partners take
immediate action while FDA develops long-term
response.
- Prioritizing enforcement follow up: After WL or major
recall, there will be a priority follow up to assess
corrections. The follow up will be within 6 months;
FDA will then take appropriate action.
- FDA will act swiftly and aggressively, i.e., no more
multiple WLs. One WL, then if necessary,
enforcement action. Action may be combined with
WL or result from follow up inspection.
- FDA will respond to firms after they have made
necessary corrections.
- FDA is developing a Warning Letter close out process: If and when all corrections are verified,FDA will issue a “Close-out Letter”; the Close-out Letter will be posted on FDA Web Page
Excerpts from a recent warning letter:
- Failure of the study director to ensure that all applicable
good laboratory practice regulations are followed. [21
CFR § 58.33(e)].
The study director failed to follow all good laboratory practice regulations (GLPs) for the nonclinical laboratory study being conducted at your facility. This violation was not cited on the Form FDA-483. However, the failures cited in this Warning Letter are all violations of the GLP regulations. The study director is responsible for assuring that all applicable GLP regulations are followed.
- Failure to establish required written standard operating
procedures (SOPs). [21 CFR § 58.81(b)(11)].
There are no SOPs for the maintenance of equipment in the Histo-Pathology Laboratory or the Cell Culture Laboratory.
A great newsletter to subscribe to is FiercePharma and Fierce Biotech. The subscription is free and provides a “pulse” of the pharmaceutical industry ( just Google it!).
As noted over and over and over – the Study Director must receive ALL SOP and protocol deviations. The reasons I continually hear for not complying with this part of the GLPs is that the Study Director has no clue about that portion of the study. If that is truly the case, perhaps you need a different Study Director. Study Directors must understand all components of their studies in order to evaluate the impact on the overall study. Fewer and fewer studies are simply “tox” studies. Study Directors may need to “broaden their horizons” and obtain additional training in disciplines such as toxicokinetics, bioanalytical, cell and gene therapy, biomarkers, neutralizing binding assays, etc. Study Directors must read the contributor reports and interpret those findings in the final report. Simply “cutting and pasting” from the contributor reports without really understanding what they are “cutting and pasting” only leads to problems. West Coast Quality
West Coast Quality Training Institute
2010 Training Schedule
Hood River, OR
- GLP 101 - April 6,2010
- GLPs for Study Directors and Monitors - April 7-8
- QA Audits, Inspections and Responsibilities - May 12-13
GLP TRIPLE PLAY
- Tto be determined