Susan Haigney

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.

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

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.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

Pharmaceutical Technology spoke with Melissa Topp, director of Global Marketing at ICONICS, about the latest in process analytical technology (PAT).

Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.

Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.

The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.

Industry experts discuss recent industry consolidation and what the outsourcing market holds for 2016.

Industry experts discuss what the outsourcing market holds for 2016.

The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

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

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA's Secure Supply Chain Pilot Program, RX-360, and other industry efforts advance actions to secure the drug supply chain.

Regulators and industry leaders take on the task of securing the drug supply chain.

Industry experts discuss challenges in managing the cold chain.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report.

FDA will use a new anticounterfeiting tool to detect fake medicines.

Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

FDA's Fiscal Year 2014 budget request includes more than $10 million above the 2012 budget for inspections of products manufactured in China.

FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions.