Channels

 

Special Offers & Promotions

 

 

Latest News

 

 

View Channel

New Products

 

 

View Channel

Video Presentations

 

 

View Channel

Separation Science

 

 

View Channel

Microscopy & Image Analysis

 

 

View Channel

Laboratory Automation & IT Solutions

 

 

View Channel

 

Mettler-Toledo experts explain how to comply with new USP regulations

publication date: Sep 17, 2013
 | 
author/source: ABI, Inc

METTLER TOLEDO’s Weighing Standard Ensures USP Compliance Free On-demand Webinar Clarifies the New Rules

USP Check-inOn the 3rd June, 2013, United States Pharmacopeia (USP) published the revised mandatory Chapter 41 on balances as well as new updates to the advisory Chapter 1251. With just six months to comply, METTLER TOLEDO’s global weighing standard, GWP®, can help pharmaceutical manufacturers and suppliers to meet the new requirements. The new revisions define modified balance test procedures for the US pharmaceutical industry and also apply to companies exporting to the US. With the revised chapters becoming official on 1st December, 2013, METTLER TOLEDO is providing a free on-demand webinar to explain how balance quality management will be affected, focusing on the determination of minimum weight and execution of routine testing. In addition, METTLER TOLEDO is also offering a wealth of information on their website including a free white paper and a video as well as the opportunity to register for an easy e-learning course.

For a long time balance users and manufacturers argued that balance assessment as per USP’s General Chapter 41 (“Balances”) was unclear and difficult to comply with. In addition, they frequently commented that General Chapter 1251 (“Weighing on an Analytical Balance”) no longer represented state-of-the-art weighing practices. The revisions to both chapters in the Second Supplement to USP 36-NF 31 aim to help US pharmaceutical manufacturers and suppliers ensure accuracy and eliminate costly over-testing. METTLER TOLEDO’s Global Weighing Standard: Good Weighing Practice™ (GWP®) can help consumers put the new standards into practice in a structured and effective way.

Demanding Balance Assessment

The new requirements of General Chapter 41 are mandatory. The revised chapter details a relatively demanding balance assessment, outlining accuracy and repeatability tests for calibrated balances used to weigh analytes for quantitative measures. Since accuracy can only be gauged using weights that are at least 5% of an instrument’s capacity, test weight selection criteria have also been modified accordingly (weights smaller than 5% cannot assess systematic deviations sufficiently well enough).

Achieve Time Savings without Compromising Accuracy

General Chapter 1251 provides additional clarification on the new procedures and extends the scope to any balance used for an analytical procedure. It details that balance performance verification should be carried out using a risk-based approach. Very importantly, it is recommended to only weigh net samples which weigh sufficiently more than the minimum weight to account for fluctuations in the balance's performance due to varying influences from the environment and the balance operators. This requirement is clearly applied to the sample weight itself—and not to the tare vessel. Additionally—and perhaps most importantly to pharmaceutical manufacturers—daily testing recommendations have been dropped. This change is expected to provide significant time savings which, if accompanied by weighing accuracy, will offer monetary savings as well.

Ensuring Accuracy in the New Environment

Although these revisions imply that unnecessary testing must be eliminated to protect manufacturing margins in today’s highly competitive pharmaceutical market, they continue to underscore that weighing accuracy is non-negotiable. METTLER TOLEDO’s GWP® —The Weighing Standard—can help manufacturers implement the new USP regulations. Tailored to each weighing application, GWP® Verification is a unique, risk-based service that helps eliminate redundant or erroneous testing. Thanks to determining the minimum weight and measurement uncertainty for each and every balance and scale used in the weighing process, manufacturers not only optimize SOPs, ensure consistent product quality and pass air-tight audits, they also avoid potentially costly litigation and fines resulting from a poorly-formulated, out-of-specification product.

Consistent Quality with GWP® Verification

With daily testing out of the way, pharmaceutical manufacturers have the opportunity to strengthen their balance testing procedures and create enhanced assurance that their products remain safe, effective, and profitable. GWP® Verification’s unique, systematic guidance can help make weighing consistency—and product quality—part of a pharmaceutical manufacturer’s everyday production reality without burdensome over-testing.


more about free On-Demand Webinar


more about Mettler Toledo




 

Subscribe to any of our newsletters for the latest on new laboratory products, industry news, case studies and much more!

Newsletters from Lab Bulletin

 

Request your free copies HERE

 

 

 

Popular this Month

Top 10 most popular articles this month

 

 

Today's Picks

 


 

Looking for a Supplier?

Search by company or by product

 


Company Name:

Product:


 

 

 

 

Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd.


 

Media Partners

 

Exhibitions & Events