In 2013, the pharmaceutical industry was challenged by a series of revisions to the United States Pharmacopeia (USP). Years later, quality managers may still feel uncertain about how they have implemented general chapter <41> and <1251> weighing revisions.
Greifensee, Switzerland—June 14th, 2016—Two years ago the USP revisions on weighing became effective. Changes to <41> and <1251> 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. market.
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. 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.
METTLER TOLEDO has helped thousands of companies feel confident in the way they have put general chapter <41> and <1251> revisions into practice. 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.
Free online resources including a new competence library help you increase confidence in ongoing compliance efforts.
These include:
A free video tutorial
A visually compelling, easy-to-follow video explores USP chapter revisions and the importance of defining testing schedules, minimum weights, and safety factors. View the informative 10-minute presentation here. [RGM1]
A free on-demand webinar
Good Weighing PracticeTM, or GWP®, provides a systematic framework to ensure users have documented evidence of reproducible results. Learn how GWP® helps users meet USP and GMP compliance by viewing the webinar here.
Additional resources to enhance weighing competence
To address compliance in a comprehensive way, METTLER TOLEDO has launched a new web-based Laboratory Expertise library. This online resource will help users streamline workflows and enhance overall accuracy and productivity.
Visit today for access to the above materials and more here.
About METTLER TOLEDO
METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. 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. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. For more, visit Mettler Toledo website.
