Quality Systems

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

Inadequate response to violations cited in a 2014 inspection leads to an FDA warning letter for Sun Pharmaceutical Industries.

The FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.

The agency has launched a new web platform to foster scientific innovation.

The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

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

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

The Safe Chain Track and Trace System automates traceability for supply chain security.

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

Pharmaceutical manufacturing facilities can help prevent contamination and cross contamination by using color coding.

FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.

Dynamic powder testing and measurement of bulk powder properties can complement shear cell testing to identify the causes of poor hopper performance in solid-dosage drug manufacturing.

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.