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April 12, 2017
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
April 01, 2017
This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.
March 20, 2017
The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.
February 15, 2017
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
January 09, 2017
The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.
December 15, 2016
The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.
December 02, 2016
Pharmaceutical companies must see regulators as partners in their efforts to provide safe and effective therapies worldwide.
Pharmaceutical Technology reached out to the US Pharmacopeial Convention (USP) to get an understanding about how pharma manufacturers can get involved in developing industry standards.
Susanne Keitel, director of the European Directorate for the Quality of Medicines and Healthcare (EDQM), discusses the role industry plays in the development of pharmaceutical standards.
November 29, 2016
The commission approved future plans, appointed members, and adopted texts during its November 2016 session.