Source: http://labcompliance.com/news/2013/05_may_news.aspx
Timestamp: 2020-08-05 19:07:28
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How to Ensure Part 11 Compliant Integrity of Laboratory Data
May 23, 20133
Labcompliance News May 2013
USP Offers Free Compendium with Testing Standards for Herbal Ingredients used in Traditional Medicines
The new Herbal Medicines Compendium (HMC) will help ensure the quality of ingredients used in traditional herbal medicines. With the first set USP proposes 23 ingredients for comment by all interested stakeholders worldwide. Standards such as those in the Herbal Medicines Compendium may be used by regulators and other stakeholders in many countries as a tool against adulterated or poor-quality herbal medicines. As of May 2013 the full article is available in the USP website.
“An Outlook on U.S. Biosimilar Competition,”
An "Outlook on U.S. Biosimilar Competition", Life Sciences Report available
The report has been released by the IP & Science business of Thomson Reuters, a worldwide provider of intelligent information for businesses and professionals The report provides a view of the challenges facing companies entering the U.S. biosimilar drug market and key players predicted to break into this developing pharmaceutical space. According to the report U.S. lags behind some other nations entering the entering the global biosimilar market, The report also review emerging regulatory developments in India and China and identifies potential leaders of the U.S. market, including Amgen, Hospira, and Sandoz. As of May 2013 more details are available on the Packworld Website. To learn more about regulatory developments of biosimilars in US and Europe, attend the Labcompliance audio seminar: Regulatory Aspects of 'Biosimilar' Drugs.
Excel is frequently used in laboratories, offices and manufacturing as sophisticated calculator. Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. To learn everything about how FDA is using Excel in their own regulated environments and about current regulatory expectations for using Excel, and to receive two FDA Spreadsheet Information Bulletins click here.
Generic Drug Manufacturer agrees to pay M$500 Fine for GMP Violations
After a year when it entered into a consent decree for serious cGMP violations, the drug manufacturer has now agreed to pay $500 million to issues with the FDA. In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India. GMP violations included faking stability data and bio equivalence data to support several drugs that were to be delivered to foreign countries. As of May 2013 the full article is available at the ibn-live website. Copyright rests with the publisher To learn everything how to ensure and document FDA compliant integrity of laboratory records attend the Labcompliance Audio Seminar "How to ensure Part 11 compliant integrity of laboratory data"
Excipient and Pharmaceutical Manufacturers Concerned about USP 232/233 Timeline
According to an article of 'in-pharma' manufacturers of pharmaceutical products and excipients raised concerns about the current requirements and timeline for elemental impurities following the new USP chapters <232/233>. According to USP publications the chapters should be implemented on May 2014 and the current chapter <231> for heavy metal analysis will be obsolete at the same time. This means the equipment must be ordered, installed and qualified, the methods must be verified if companies choose one of the two compendial methods or validated for alternative methods. In addition SOPs should be in place for routine use and personnel must be trained. The article also reported that the FDA began setting up a laboratory which took half a year. As of May 2013 the full article is available in the 'in-pharmatechnologist website. Copyright rests with the publisher. To learn everything about elemental impurities according to USP 232/233 attend the Labcompliance Audio Seminar 311.
Laboratory Data Integrity Issues Cited as FDA GMP Deviations
Data integrity and security issues are not only 21 CFR Part 11 issues but severe GMP violations. Corresponding citations have been cited in FDA warning letters and 483s even long before Part 11 has been issued. Examples from a 483 inspectional observation are: "Operations that could affect the integrity of chromatographic data files collected and processed by the data acquisition system are not controlled by electronic audit trails that maintain who, why and what was changed to any given sample record", "The firm does not electronically store all integration parameters and chromatograms", "There are insufficient security measures in effect to ensure the integrity of chromatographic data housed in the Quality Control Laboratory", and "The firm lacks the controls necessary to ensure the integrity of raw data generated by the laboratory computer system". It is interesting that similar type of Part 11/GMP violations have been recently cited as part of FDA's Part 11 inspection initiative from 2010 to 2013. To get full access to the 483 and to learn everything how to ensure and document FDA compliant integrity of laboratory records attend the Labcompliance Audio Seminar "How to ensure Part 11 compliant integrity of laboratory data.
As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the Best Practice Document "SOP: Subcontracting of Testing and Calibration". To download your free copy, go to the ISO 17025 Accreditation Package website.. Scroll down and click on the corresponding ICON on the left (offer expires on June 10, 2013). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here
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