Labcompliance News, September 2009
FDA Issued Import Alert
Against Drugs from Canadian Manufacturer
The FDA has put an import alert against
products manufactured at two facilities of Apotex, the biggest
pharmaceutical drug manufacturer in Canada. This is an other
example, that the FDA is taking enforcement more series. The import
alert followed an inspection from December 2008 with several 483
observations and a
warning letter from June 2009. According to the letter the
company mainly failed to adequately investigate Out-of-specification
test results. For example the letter states: "The initial assay
failure occurred in March 2008 and your investigations of these
initial OOS test results had not been completed at the time of the
inspection, nor had your QC unit identified a root cause for the
assay failures".
Click here to read more. Attend the
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Audio seminar
to learn everything about OOS, failure investigations and to develop
and follow up on corrective and preventive action plans.
Laboratory Compliance
Package Version 2 Released
Labcompliance has developed a new release of
it's popular Laboratory Compliance Package. Now it includes 46 SOPs,
25 of which are new additions. The package also includes an updated
Laboratory Compliance Master Plan, a new Step-by-Step implementation
guide, a new question and answer section and many new forms,
templates and examples. The package is available in traditional
CD/Binder format and as web download. For more information and
ordering
click here.
FDA Updates "Warning
Letters" Web page
On Sept 10 the FDA announced the
reorganization of the warning letters page. Most important is the
addition of closeout letters. Such letters are issued after the FDA
has verified corrective actions through follow-up inspections. The
FDA office that originally sends a warning letter will also be
responsible for issuing the closeout letter. To see FDA's
announcement,
click here
FDA's Acceptance of
Corrective Work Plan Sends Shares 40 % up
It is well known that cGMP compliance or
noncompliance can have a high impact on a company's business. This
became obvious when shares of drug manufacturer K-V Pharmaceutical
Co went up 40 after the FDA accepted a work plan to correct
previously identified cGMP deficiencies. The company plans to hire
an external cGMP expert as consultant to conduct a cGMP
certification review. If in compliance the company expects the FDA
to re-inspect the facilities to determine if it is in compliance.
The article has been published by
Reuters and as of September 2009 is
available on the publishers website. Copyright rests with the
publisher.
EMEA Mandates Electronic
Submissions in eCTD format by January 2010
On September 3, 2009, the
EMEA reminded the industry
that from January 1, 2010, the EMEA will mandate the use of
the eCTD format for all electronic-only submissions for all
applications (new and existing) and all submission types. In the
final step of its phased introduction of the use of the Electronic
Common Technical Document (eCTD) format, the European Medicines
Agency will require that the eCTD format be used for all
applications relating to medicinal products for human use. To see
the original announcement,
click here. The EMEA has also published
Q&As about EMEA implementation of electronic-only submissions
and mandatory eCTD submission
A Comparison
of CROs in India and China
Contract research organizations (CROs) in China
and India are perceived to offer a lower cost alternative for
pharmaceutical companies that are looking to outsource R&D
activities. Pharmasia has published results of an interesting study
about contract research organizations in both countries. The study
was conducted on
the top 50 outsourcing service providers in each country.
The article reveals the similarities and
differences between the two countries, their advantages and
disadvantages in pharma outsourcing, and their strengths and
weaknesses in service capabilities. According to the study Indian
companies tend to be more familiar with western regulations than
Chinese companies. They also tend to have more extensive global
operations. China however, is better equipped in terms of industry
infrastructure. The Chinese pharmaceutical market is also much
bigger than India's. As of September 2009 the article is available
on the
Pharmasia
website. Copyright rests with the publisher.
Labcompliance Computer System
Validation Package Available as Download
The popular Computer System Validation Package is
now available as download version, in addition to traditional
CD/Binder Version. The package includes 35 SOPs, master and project
plans, 31 examples/forms/templates, two audio seminars and two years
free online updates. The package helps to develop strategies for
software and computer system validation and it has the tools for
trouble free implementation. For details on content and ordering,
click here.
Free Document of the Month
As a 'Thank You' for our visitors
Labcompliance offers every month one document for free. This month's
document is the SOP: Reserve samples in Laboratories. To download
your free copy, go to the
Laboratory Compliance Package website. Scroll down and
click on the corresponding ICON on the left (offer expires on
September 30, 2009). Labcompliance offers more than 100 SOPs that
help to comply with FDA and ISO 17025 compliance. For titles and
ordering, click
here.
New Audio Seminar Schedule
New or Updated Sites