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Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Calibration and  Qualification of in Analytical Laboratories
With examples from planning to reporting
Recorded, available with all reference material at any time

 

Managing OOS, failure Investigations and CAPA
Understanding and Implementing FDA Requirements
Recorded

 

New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters

 

 

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 Labcompliance 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. 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.

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