Quality Systems

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.

Statistical procedures give statistical answers not analytical judgement.

US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Richard Johnson, President and CEO of the Parenteral Drug Association (PDA) speaks with Pharmaceutical Technology.

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, spoke with Pharmaceutical Technology about resolving drug shortages.

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, speak with Pharmaceutical Technology.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

A recent Ernst & Young survey highlights the challenges facing Indian pharma

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The agency takes action against websites that illegally sell unapproved medications.

The International Conference on Harmonization finalizes Q&A document on APIs.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

The agency streamlines risk and mitigation information.

The agency publishes guidance on the physical attributes of generic tablets and capsules.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Although full traceability is not required by law in the US until 2023, companies could benefit from implementing it now.

The agency creates initiative to stimulate pediatric drug development.

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).