Quality Systems

FDA orders unapproved prescription ear drop products with active ingredients removed from the market.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

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.