Quality Systems

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

A European task force outlines its upcoming efforts to combat drug shortages.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

This pharma insight briefing from Agilent Technologies will cover the application of Raman and infrared spectroscopy for pharmaceutical quality control (QC).

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

CDER director plans to start implementation of new review practices by the end of 2018.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

The agreement now includes 15 European Union (EU) member states.

The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom, a potential source of opioids, with unproven medical claims.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Sharing know-how can help resolve common bio/pharma technical challenges.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.