Compendial Compliance

The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.

Industry experts were honored for business, scientific, and social contributions.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

The directorate highlights its 2016 achievements.

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.

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 new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

This article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.

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.

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

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

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.

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 authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

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

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

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.