Quality Systems

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

Articles

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

The UK’s General Pharmaceutical Council (GPhC) has strengthened its guidance for online pharmacies to further safeguard patients when purchasing medicines.


General Pharmaceutical Council Introduces Further Safeguards for Online Medicines Purchases

The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.

CHMP Recommends Implant for Opioid Dependence

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.


EMA Updates Prescribing Information of Breast Cancer Medicine while Data are Re-Analyzed

Sean Milmo is a freelance writer based in Essex, UK.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Playing the Waiting Game with GMP Guideline Revisions

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

Broadening Europe’s Research Horizons

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

A Meeting of Minds

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

Alcami’s St. Louis Facility Issued European Medicines Agency Certification

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.

RAPS Releases Updated Agenda for Forthcoming Regulatory Conference

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Regulatory/GMP Compliance, Europe