Quality Systems

EDQM clarifies elemental impurities guidelines for veterinary and other products.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

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

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

To enable efficient monitoring systems, life-science companies need to effectively apply run rules.

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.