Four JP Drafts Related to Balances Published for Public Comments

Practical Statistical Tools for Analytical Laboratories

Recommendation

1/2 October 2024
Barcelona, Spain

Practical Statistical Tools for Analytical Laboratories
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has announced the availability of four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Balances.

The following documents have been published on the PMDA website:

Draft of revised General Test “<9.62> Measuring Instruments, Appliances”
Draft of new General Information “<G1-6-182> Concept of Weighing in the Japanese Pharmacopoeia”
Draft of new General Information “<G1-7-182> Calibration, Inspection, and Weight of a weighing instrument (balance)”
Draft of new General Information “<G1-8-182> Installation Environment, Basic Handling Method, and Precautions for Weighing of a Balance”

The PMDA also published a Briefing Note in which the key points of these four drafts are summarised. It is pointed out that the drafts "were developed by referring to the content and requirements provided in United States Pharmacopeia and European Pharmacopoeia."

It is planned to include the chapters in Supplement II to the Japanese Pharmacopoeia 18^th edition.

Comments can be submitted until 31 March 2023. For this purpose, a form for comments has to be downloaded and sent by e-mail after it has been filled in.