Regarding the fundamental approach for qualification it is referred to USP Chapter on Analytical Instrument Qualification. Unlike General Chapter, Chapter isn't binding. It is planned to replace the title of General Chapter "Weights and Balances" by "Balances" and also to revise General Chapter "Weighing on an Analytical Balance".Ĭhapter provides background information and advice regarding the qualification of analytical balances - also in concrete terms for OQ and PQ including possible tests. In the Pharmacopeial Forum 38/5 two proposals have been published about the revision of the two General Chapters on analytical balances. GMP Courses & Conferences on Site (in hotels).Additional information about METTLER TOLEDO can be found at. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. The Company also holds top-three market positions for several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications.
METTLER TOLEDO is a leading global manufacturer of precision instruments. Visit today for access to the above materials and more here. This online resource will help users streamline workflows and enhance overall accuracy and productivity. To address compliance in a comprehensive way, METTLER TOLEDO has launched a new web-based Laboratory Expertise library. Learn how GWP® helps users meet USP and GMP compliance by viewing the webinar here.Īdditional resources to enhance weighing competence Good Weighing PracticeTM, or GWP®, provides a systematic framework to ensure users have documented evidence of reproducible results. View the informative 10-minute presentation here. This has often been in the form of a GWP® Verification, a service that determines the minimum weight of balances and provides a risk-based test plan and SOP to meet all USP and GMP requirements.įree online METTLER TOLEDO resources designed to help users understand and implement the changes are also available, including:Ī visually compelling, easy-to-follow video explores USP chapter revisions and the importance of defining testing schedules, minimum weights, and safety factors.
METTLER TOLEDO has helped thousands of companies feel confident in the way they have put general chapter revisions into practice. Confusion also remains around accuracy requirements and the definition of minimum weights to ensure safe weighing of APIs, solvents, and other agents that affect potency and toxicity. However, because the revisions left latitude for manufacturers to define their own testing schedules based on risk, some quality managers may still feel uneasy about changing their testing SOPs even though these changes could enhance productivity. Changes to were intended to reflect the realities of weighing on modern equipment and reduce burdensome daily balance testing for pharmaceutical companies that manufacture in or sell to the U.S. Two years ago the USP revisions on weighing became effective. Greifensee, Switzerland (PRWEB) June 14, 2016
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