Susan Haigney

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

Industry experts discuss best practices for certificates of analysis.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.

Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, discusses how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.