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July 07, 2015
A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.
July 02, 2015
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.
July 01, 2015
An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.
Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, spoke with Pharmaceutical Technology about resolving drug shortages.
June 24, 2015
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
June 19, 2015
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
June 18, 2015
The agency publishes guidance on the physical attributes of generic tablets and capsules.
June 17, 2015
Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.
June 09, 2015
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.