This free 30-minute webinar with Q&A session, is being held on 15 June and 29 June 2021, presented by Dr Klaus Fritsch, Compliance Manager, Mettler-Toledo. Details of specific requirements for calibration, and performance checks for accuracy and repeatability will be presented and explained, along with advice on how to apply these requirements and how to prove compliance for audit purposes.
General Chapter 2.1.7 ‘Balances for Analytical Purposes’ covers and understand the implications for your weighing processes. The new regulations, published in July 2021 must be fully complied with after a 6-month transition period, by 1 January 2022.ĭuring this live webinar, you will learn what the new Ph. The European Pharmacopoeia is the single legally binding reference work for the quality control of medicines in its European member states, or any pharmaceutical company who exports into the European market. General Chapter 2.1.7 ‘Balances for Analytical Purposes’, published on 1 July 2021.
from Mettler-Toledo explains everything you need to know to ensure compliance with the new Ph. In consideration of these similarities and differences among three pharmacopoeias and characteristics of JP, we expect that JP will be not only enriched its contents but also more convenient for users.This live webinar ‘Weighing According to Ph. and USP had more chapters for control of impurities than JP. The comparison also clarified that JP uses a term of “Being specified separately” in the general notices 11 to describe a relationship with approval documents, but USP and Ph. In addition, all three pharmacopoeias stated comprehensive rule in general notices. As a result, although the constitution among three pharmacopoeias was not completely same, their basic concept that the test methods and monographs are described in assuming following the general notices was common.
Then, we compared the three pharmacopoeias about constitution, general notices which are fundamental to understand pharmacopoeia and status of provision on control of impurities which is one of the highest interest in the area of pharmaceutical quality. utilized worldwide is useful for harmonization activity in PDG and getting all users to use JP appropriately. Therefore, to clarify characterization of JP comparing with USP and Ph. In addition, utilization of JP as a reference pharmacopoeia in Asian region is aimed by the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency of Japan. For example, harmonization of test methods and monographs is conducted by Pharmacopoeial Discussion Group (PDG) which consists of JP, the United States Pharmacopeia (USP), and the European Pharmacopoeia (Ph.
The Japanese Pharmacopoeia (JP) is promoted internationalization in line with globalization of supply chain for pharmaceuticals.
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