The Regulatory Review Committee of the Society of Quality Assurance met in Raleigh, North Carolina on Thursday April 8, 1999. This was the second meeting hosted by a Regional Chapter (the first being last year at Genentech, hosted by PRCSQA). The following summarizes highlights of the FDA and EPA subcommittees:
International
China is getting ready to publish their own set of GLPs and GCPs. They will not be OECD, China is developing their own regulations.
Food and Drug Administration
The status of the TURBO EIR (public access database) program is uncertain. The prototype has been developed but it could be several years before implementation. At this time it does not appear that the database will be available to the general public.
A notice in the November 1998 Federal Register appeared to indicate that FDA would begin giving notice on all inspections. FDAÕs clarification indicted that general GLP inspections will continue to be unannounced, Medical Device, IRB and Clinical Investigator inspections will be announced. This is an effort by FDA towards compliance assistance and to get the Device companies more in compliance.
Computerized systems Ð Hardware and software must be retained when computer systems are retired. A company must also have a written plan on how to maintain the system once retired. Companies must be able to boot up and access the original system to show investigators how data were captured and stored.
SQA CVIC recently met with FDA. The results of the meeting will be made available in the next SQA newsletter.
A clarification was made regarding the retention time frames for data as required by GLP. Although the US GLPs state data must be retained for 2 years after drug approval, it was noted that US data are often used for registration in other countries. Technically, according to ICH this extends the retention period for data, specimens and samples to 2 years after registration in the last country using the data for approval. Therefore, the retention time period is indefinite.
John Freel of the Commissioners office is requesting that when questions are submitted to FDA, the submittor also include what they perceive as the correct answer.
An article "Computer Validation: Available Document Resources from FDA" was published in the March 1999 issue of Pharmaceutical Technology.
A recent FDA inspection focusing on electronic data systems resulted in the following items on the 483:
No GLP training for computer personnel
No documentation that electronic data had been archived or where
No QA inspection on the IBM CPU systems
Lack of a high level document on the systems overview, including the operational environment.
An additional trend in all current FDA inspections is a requirement that Study Directors be aware of ALL data systems in their studies. FDA appears to be focusing on Y2K compliance.
CVM is restructuring as they are too top heavy. The new phone directory is on their web page. Currently, CVM is spending 74% of their time on report reviews.
Environmental Protection Agency
Not much is happening on the EPA GLP front. The proposed merged GLPs are still on "someones" desk and no one seems to know when they will be published. The SQA subcommittee has drafted a ~50 page response to the draft proposed document, and are based on harmonizing OECD, FIFRA, TSCA and FDA. The SQA response will be available on the SQA web page once the proposed rule is published. Companies are urged to use the SQA template for their responses and can submit it verbatim if desired.
ACPA has a workgroup developing standardized final report templates for submission of Efate reports that would satisfy both OPP and PMRA. The template is based on the Canadian PMRA guidelines, EPA GLPs, DRGs, and PR86-5.
It appears that ELAB will recommend that the GLP issue (and therefore studies and facilities) not be included in NELAP.
Greenpeace has filed a lawsuit against EPA over what it claims is EPAs approval action on gene-altered crops.
The EWG issued a "renewed call for a ban" on methyl parathion.
The US EPA expects to meet its target of reassessing one-third of all pesticide tolerances by 8/3/99, as required by the 1996 FQPA. The agency has completed 2,308 tolerance reassessments and is confident of reaching itÕs target of some 3,210 tolerances. Over 65% of the tolerances reassessed so far are from the priority group of OPs, carbamates, organochlorines, carcinogens and high hazard inerts. However, all tolerances from this group will not be reassessed by the target due date due to the complexities of redefining risk assessment. The EPA is currently revising the risk assessments for OPs and expects to complete the process of cumulative risk assessments by the end of 2000. Priority group pesticides account for 38% of the total number of tolerances subject to reassessment. OPs account for 17.5%, carcinogens 12.2%, carbamates 5.6%, organochlorines 2.6%, and inerts 0.2%. The EPA has completed 18% of the OP tolerance assessments, 40% of carbamates, 20% of organochlorines and 36% of carcinogens. While no high hazard inert tolerances have been reassessed, 22 of the 24 tolerances are for formaldehyde, which should be completed by August 3rd.
- Debi Garvin