Quality Systems

Data integrity is a widespread, global problem that must be addressed.

Standardized testing protocols are crucial for acceptance of single-use systems.

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

The program is intended to provide support to ongoing efforts in rare disease product development.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

The directorate is looking for experts to join the European Pharmacopoeia network.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

The agency prepares a plan to implement new packaging safety features.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

The author reviews FDA's final Animal Rule guidance.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.