USP Chapter 41 Weighing Requirements White Paper
This white paper comprehensively explains the requirements of the 2019 versions of USP General Chapters <41> and <1251> and provides advice on how to put these requirements into practice. Weighing according to USP requirements will ensure that a consistently high quality of weighing results is achieved and is applicable to all pharmaceutical QC activities globally, not just those operating in the USA.
Download the White Paper on USP Requirements for WeighingThe Japanese Pharmacopoeia (JP) on Balances General Tests 9.62 “Measuring Instruments, Appliances – Balances & Weights” will be published in July 2024 as part of the Japanese Pharmacopoeia Supplement II to JP18th edition.
What Is New?
JP General Tests 9.62 addresses equipment performance and introduces measures that must be carried out periodically to optimize balance performance:
- Calibration must be documented in a calibration certificate and must include measurement uncertainty
- Repeatability and accuracy are the two performance checks that must be executed between calibration intervals
- Highlights the importance of as-found and as-left calibration
JP 9.62 requirements describe the same tests and criteria as USP41 and Ph.Eur. 2.1.7.
How Can METTLER TOLEDO Support You?
METTLER TOLEDO offers the "Japanese Pharmacopoeia General Tests 9.62 Measuring Instruments, Appliances" certificate to meet this requirement.
The certificate provides a thorough evaluation of balance repeatability and accuracy in line with stipulated requirements. Additionally, you can also obtain an independent document that verifies the balance's compliance with the identical requirements outlined in USP General Chapter 41 and/or Ph. Eur. General Chapter 2.1.7.
What Are the Key Requirements of JP 9.62?
Similar to the Ph. Eur., the Japanese Pharmacopoeia (JP) has specific requirements for balances used for analytical purposes. Therefore, our video Ph. Eur. 2.1.7. and our whitepaper are an excellent source to learn more about these requirements and criteria.
Who Is Affected by JP General Tests 9.62?
The Japanese Pharmacopoeia (JP) is the official pharmacopoeia of Japan and serves as a legal basis for the quality control of drugs. It sets standards for the quality, safety, and efficacy of pharmaceutical products that are marketed in Japan. It is therefore also binding for Pharmaceutical companies in other regions of the world who intend to export into the Japanese market. As such, it has a similar legal status to the USP Compendium in the United States and is enforced by regulatory bodies as part of compliance with Good Manufacturing Practice.
FAQ
What is the scope of JP General Tests 9.62?
The scope of General Chapter 9.62 covers balances for analytical purposes. Therefore, any weighing described in a monograph of the European Pharmacopeia must comply with the principles of the chapter.
Note: JP is a reference work for quality control of drugs. The chapter is not applicable for the manufacturing of pharmaceuticals.
How can I ensure compliance with the JP General Tests 9.62?
The chapter addresses equipment performance and introduces measures that need to be carried out periodically to control and improve the performance of the balance:
- Calibration must be documented in a calibration certificate and must include measurement uncertainty
- Repeatability and accuracy are the two performance checks that must be executed between the calibration intervals
- Highlights the importance of as-found and as-left calibration
I am compliant with USP 41. Do I also need a Japanese Pharmacopoeia Certificate?
Yes. Each certificate has dedicated statements to document compliance according to the specific pharmacopoeia. When references are made in the customer documentation, they can be specifically related either to JP General Tests 9.62 or to USP General Chapter 41.
Does JP 9.62 require both 'as found' and 'as left' data in the calibration certificate?
It is not a mandatory requirement, but it is strongly recommended for traceability. If a calibration is carried out with no adjustment afterwards, it means that the as-found calibration already fulfils the requirements of the Japanese Pharmacopoeia. In this specific case, an as-left calibration is obsolete and the as-found calibration data are also considered to be as-left-calibration data.
Documents
Zertifikate USP 41 und Ph. Eur. 2.1.7
Die Kapitel USP 41 und Ph. Eur. 2.1.7 befassen sich mit der Geräteleistung und stellen drei Massnahmen vor, die zur Optimierung der Leistung von Analysenwaagen regelmässig durchgeführt werden müssen
Europäisches Arzneibuch Kapitel 2.1.7
Laden Sie ein kostenloses White Paper als PDF herunter, um sicherzustellen, dass Ihre Wägeprozesse konform sind mit Ph. Eur. Kapitel 2.1.7. Stellen Sie die Einhaltung der neuesten Richtlinien sicher.
USP Kapitel 41 – Wägeanforderungen
In diesem White Paper werden die Wägevoraussetzungen von USP Kapitel 41 – „Wägeanforderungen für Waagen“ und Kapitel 1 251 – „Wägen auf einer Analysenwaage“ erklärt. Erfahren Sie, wie Sie eine gleichbleibend hohe Ergebnisqualität sicherstellen können.
USP Guidelines for Weighing in the Pharmaceutical Industry
This reference paper explains the USP Chapters 41 and 1251 on weighing and how to ensure compliance. A risk-based approach to optimize balance calibration and testing is presented.
Webinars, Videos and eLearnings
Webinar: Europäisches Arzneibuch „Waagen für Analysezwecke“
In diesem Webinar wird das neue Allgemeine Kapitel 2.1.7 „Waagen für Analysezwecke“ des Europäischen Arzneibuchs erläutert.
