Compendial Compliance

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The agency published a guideline for the implementation of ICH Q3D.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The agency now allows production of water for injection by non-distillation technologies.

The directorate is looking for experts to join the European Pharmacopoeia network.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

USP responds to FDA's draft guidance on the naming of biological products.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

Will biosimilars share a compendial identity like generic drugs do?